Khoom Description
Cromolyn sodium hmoovyog ib tug mast cell stabilizer muab tau los ntawm cov extract ntawm cov nroj tsuag * Ammi visnaga *, thiab yog ib tug kws tshuaj. Nws lub luag haujlwm tseem ceeb yog ua ntej - txhim kho mast cell daim nyias nyias, tiv thaiv kev tso tawm ntawm sensitizing mediators xws li histamine thiab leukotrienes, yog li tiv thaiv kev tsis haum tshuaj thiab o. Nws tsis muaj bronchodilator, antihistamine, los yog steroid anti- cov teebmeem inflammatory. Clinically, nws yog siv nyob rau hauv ntau yam tshuaj, xws li inhalation, qhov muag tee, tshuaj tsuag qhov ntswg, thiab qhov ncauj kev tswj, rau kev tiv thaiv ntawm bronchial hawb pob, allergic rhinitis, allergic qhov muag kab mob, thiab systemic mastocytosis. Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias nws muaj qhov pib ua haujlwm qeeb, feem ntau xav tau ob peb lub lis piam ntawm kev siv tas mus li kom ua tiav qhov kev tiv thaiv zoo, thiabtsis tuaj yeem siv los daws qhov mob hawb pob lossis mob ua xua tsis tu ncua. Tsis tas li ntawd, nws qhov kev nqus ntawm qhov ncauj yog qhov tsawg kawg nkaus (tsawg dua 1%), thiab kev tswj hwm qhov ncauj tsuas yog tsim nyog rau cov teeb meem hauv plab hauv zos; cov tshuaj concentrated yuav ua rau khaus ntawm daim tawv nqaij thiab mucous daim nyias nyias.

Kev Tswj Xyuas Zoo
1.
| Cov khoom kuaj | Hom Specification |
|---|---|
| Qhov tshwm sim | Dawb rau tawm -dawb crystalline hmoov |
| Solubility | Dawb soluble hauv dej; me ntsis soluble hauv ethanol |
| Kev txheeb xyuas | Infrared spectrum (IR) thiab ultraviolet spectrum (UV) raws li tus qauv siv |
| pH | 5.0 - 7.0 (1% aqueous tov) |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 10.0% |
| Hnyav Hlau | Tsawg dua lossis sib npaug li 0.002% |
| Oxalate | Tsawg dua lossis sib npaug li 0.35% |
| Yam khoom muaj feem | Txhua tus neeg impurity Tsawg dua lossis sib npaug li 0.5%; tag nrho impurities Tsawg dua lossis sib npaug li 2.0% (nyob ntawm qib khoom) |
| Assay (raws li anhydrous hauv paus) | 98.0% - 101.0% (USP qib) |
2. Assay thiab Purity Standards
|
Qib Kawm |
Kev Xav Tau |
Hauv paus |
|---|---|---|
|
API Qib (USP) |
98.0% - 101.0% (raws li anhydrous hauv paus) |
USP Txuj |
|
Inhalation Powder Formulation |
95.0% - 125.0% ntawm tus nqi sau npe |
Cov qauv tsim tshwj xeeb |
|
Kev Tshawb Fawb Qib Reagent |
Ntau dua lossis sib npaug li 95% |
Cov khoom specification |
|
Secondary Reference Standard (CRM) |
Traceable rau thawj cov qauv xws li USP, EP |
ISO 17034 Ntawv pov thawj |
3. Kev txheeb xyuas thiab kev txwv tsis pub muaj
|
Cov khoom kuaj |
Txoj kev / txwv Standard |
|---|---|
|
Kev txheeb xyuas |
Infrared spectroscopy (IR), ultraviolet spectroscopy (UV) piv nrog cov qauv siv |
|
Yam khoom muaj feem |
Nyias txheej chromatography (TLC) rau kev kuaj xyuas cov khoom cua thiab degradation impurities |
|
Cov ntsiab lus dej |
Tsis ntau tshaj 10.0% |
|
Hnyav Hlau |
Tsis ntau tshaj 0.002% |
|
Oxalate |
Tsis ntau tshaj 0.35% |
|
pH |
Yuav tsum ua raws li cov tshuaj pharmacopoeia tau teev tseg |
4. Assay Method
|
Yam khoom |
Kev piav qhia |
|---|---|
|
Txoj kev |
UV-Vis Spectrophotometric |
|
Cov xwm txheej |
pH 7.4 phosphate buffer, nrhiav pom wavelength approx . 326 nm |
|
Kev siv |
Muab xam los ntawm USP tus qauv siv |
Khoom siv
1. Qhov ncauj Inhalation - Tiv thaiv kev mob ntsws asthma
Qhov no yog qhov ntxov tshaj plaws thiab feem ntau daim ntawv thov. Kev tswj hwm ntawm cov hmoov qhuav inhalation los yog nebulized tov, nws yog siv rau lubtiv thaivntawm ntau hom kev mob hawb pob (xws li kev ua xua mob hawb pob thiab kev tawm dag zog- mob hawb pob). Nws stabilizes mast cell daim nyias nyias nyob rau hauv cov hlab cua, tiv thaiv allergens los yog irritants los ntawm triggering pa constriction thiab o. Nws yuav tsum tau hais tias nws yog ib tugtu tshuaj tiv thaiv, feem ntau yuav tsum tau siv cov txheej txheem txuas ntxiv rau ob peb lub lis piam kom ua tiav qhov kev tiv thaiv siab tshaj plaws, thiab nws tsis muaj kev cuam tshuam ncaj qha rau kev mob hawb pob uas tau tshwm sim lawm.
2. Intranasal Administration - Tiv thaiv kev ua xua rhinitis
Kev tswj hwm ntawm qhov ntswg tshuaj, Cromolyn sodium hmoov yog siv rau covtiv thaivthiab tshem tawm cov tsos mob raws caij nyoog los yog ib xyoos ib zaug xws li txham, qhov ntswg, thiab qhov ntswg congestion. Pib noj tshuaj 1-2 lub lis piam ua ntej pib qhov kev tsis haum tshuaj feem ntau ua rau cov txiaj ntsig zoo.

3. Ophthalmic Topical Use - Kev Tiv Thaiv Kab Mob Qhov Muag
Kev tswj hwm ntawm qhov muag tee, nws yog siv rau lubtiv thaivthiab kev kho mob ntawm ophthalmic allergic tej yam kev mob xws li vernal keratoconjunctivitis thiab allergic conjunctivitis, zoo relieving qhov muag khaus, tearing, thiab photophobia.
4. Oral Administration - Systemic Mastocytosis
Qhov no yog thawj qhov qhia rau qhov ncauj ntau npaum li cas (cov kua hauv qhov ncauj) ntawm Cromolyn Sodium, siv los kho tus mob tsis tshua muaj -systemic mastocytosis. Hauv cov neeg mob, muaj ntau tus lej ntawm qhov txawv txav mast hlwb hauv ntau yam kabmob thoob plaws lub cev. Qhov ncauj Cromolyn Sodium ua ncaj qha rau ntawm plab hnyuv mucosa hauv zos, txo cov tsos mob ntawm plab hnyuv xws li raws plab, xeev siab, thiab mob plab. Nws yog tsim nyog sau cia tias qhov nqus ntawm qhov ncauj ntawm Cromolyn Sodium yog qhov tsawg heev (kwv yees li 1%); Yog li ntawd, kev tswj hwm qhov ncauj tsuas yog ua rau muaj kev cuam tshuam hauv zos thiab tsis muaj kev kho mob tseem ceeb ntawm cov tsos mob.
Txheej txheem ntau lawm
Kev tsim thiab kev tsim khoom ntawm Cromolyn Sodium Powder feem ntau npog ob theem tseem ceeb:tshuaj synthesisthiabhmoov engineering kho. Tus qub txiav txim siab txog cov tshuaj purity ntawm cov khoom tiav, thaum lub sij hawm tom kawg muab cov hmoov lub cev muaj zog rau cov ntaub ntawv tshwj xeeb (tshwj xeeb tshaj yog qhuav hmoov inhalation).
1. Chemical Synthesis Theem
Qhov no yog cov txheej txheem tseem ceeb tshaj plaws, feem ntau yog siv peb txoj hauv qab no -kab ruam classical:
Kauj Ruam 1: Condensation. Siv 2,6-dihydroxyacetophenone ua cov khoom pib, cov tshuaj tiv thaiv condensation yog nqa tawm nrog epichlorohydrin nyob rau hauv alkaline tej yam kev mob los tsim ib tug tseem ceeb bimolecular choj intermediate.
Kauj Ruam 2: Ntiv nplhaib kaw. Qhov nruab nrab nruab nrab saum toj no raug rau cov tshuaj tiv thaiv cyclization nrog diethyl oxalate nyob rau hauv ib qho chaw muaj zog alkaline kom tau txais cov precursor ester ntawm cromoglycic acid.
Kauj Ruam 3: Hydrolysis, ntsev tsim thiab purification. Cromoglycate ester yog hydrolyzed los ntawm alkali thiab hloov mus rau hauv sodium ntsev, ua raws li decolorization nrog activated carbon adsorption thiab purification los ntawm recrystallization nrog ethanol kom kawg tau siab -purity Cromolyn Sodium active tshuaj muaj.

2. Powder Engineering thiab Formulation Stage
Lub active tshuaj muaj nyob rau hauv synthesis feem ntau yog cov pa crystalline hmoov. Txawm li cas los xij, rau cov ntawv thov tshwj xeeb xws li kev tswj hwm kev nqus pa, "particle engineering" thev naus laus zis yuav tsum tau siv los hloov kho lub microscopic morphology ntawm cov hmoov txhawm rau txhim kho nws cov txiaj ntsig hauv kev nkag mus rau hauv lub ntsws.
- Txoj kev Txau kom qhuav: Tam sim no txoj kev paub tab tshaj plaws. Cromolyn Sodium yog npaj rau hauv ib qho kev daws, dispersed mus rau hauv cov tee dej los ntawm ib tug atomizer, thiab cov kuab tshuaj yog tam sim ntawd evaporated nyob rau hauv ib tug kub cua kwj kom ncaj qha tau qhuav zoo hmoov.
- Hloov Kho Tshuab ziab khaub ncaws: Optimized raws li cov txheej txheem ib txwm muaj, nws tuaj yeem npaj cov khoom ntxeem tau nrog ntau cov qauv morphology, nceb -zoo li tus lossis kheej kheej. Cov khoom zoo li no muaj qhov nqus tau ntau dua thiab lub ntsws tso tawm tus nqi thaum nqus tau, thaum txhim kho cov teeb meem ntawm qhov loj me me faib thiab cuam tshuam rau kev nqus dej noo thiab caking pom hauv cov txheej txheem ib txwm muaj.
Cim npe nrov: Tuam Tshoj cromolyn sodium hmoov manufacturers, lwm tus neeg, Hoobkas

