Xigasho degdeg ah oo wanaagsan, la-taliyayaal xog-ogaal ah si ay kaaga caawiyaan inaad doorato badeecada saxda ah ee ku habboon dhammaan baahiyahaaga, waqti wax-soo-saar gaaban, koontarool tayo leh oo mas'uul ah iyo adeegyo kala duwan oo ku saabsan bixinta iyo dhoofinta arrimaha warshadda qiimaha jaban ee Fasalka Warshadaha Pancreatin ee Qalab Ceyriin ah oo dheefshiidka leh Shahaadada GMP , Waxaan ku dadaali doonaa inaan la kulano ama dhaafno baahida macaamiisha alaab tayo wanaagsan leh, fikrad horumarsan, iyo shirkad guul iyo waqti ku habboon.Waxaan soo dhawaynaynaa dhammaan macaamiisha.
Xigasho degdeg ah oo wanaagsan, la-taliyayaal xog ogaal ah si ay kaaga caawiyaan inaad doorato badeecada saxda ah ee ku habboon dhammaan baahiyahaaga, waqti wax soo saar gaaban, koontarool tayo leh oo mas'uul ah iyo adeegyo kala duwan oo loogu talagalay bixinta iyo dhoofinta arrimahaShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada DheefshiidkaShirkaddayadu waxay sii wadi doontaa inay u hoggaansanto "tayada sare, sumcadda, adeegsadaha marka hore" si daacad ah.Waxaan si diiran u soo dhawaynaynaa saaxiibo ka kala socda qaybaha kala duwan ee nolosha si ay u soo booqdaan oo ay u bixiyaan hagitaan, wada shaqeeyaan oo ay abuuraan mustaqbal ifaya!
1. Dabeecadaha: Pancreatin waa budo yar oo bunni ah, budo amorphous ah ama wax yar oo bunni ilaa midab kareem leh.Waxay ka kooban tahay amylase, lipase iyo protease.
2. Isha Soosaarka: Beeryarada Porcine.
3. habka: Pancreatin waxaa laga soo saaray beeryarada doofaarka caafimaadka qaba iyadoo la adeegsanayo tignoolajiyada firfircoonida-saarista.
4. Tilmaamaha iyo isticmaalka: Pancreatin waa isku dhafka dhowr enzymes dheefshiidka oo ay soo saarto xameetida porcine.Waxaa loo isticmaali karaa warshadaha dawooyinka, diyaarinta cuntada, haragga, dhaqida iyo beeraha kale, oo leh codsiyo kala duwan.
Waxa lagu soo saaray aqoon-is-weydaarsiga GMP
· 27 sano oo enzyme noole R&D taariikhda
Walxaha ceeriin waa la raadin karaa
U hoggaansamaan heerka macaamiisha
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | |||
CP | EP | USP | ||
Jilayaasha | Budada | Wax yar oo bunni ah, budo amorphous ah | Wax yar oo bunni ah, budo amorphous ah | Wax yar oo bunni ah, budo amorphous ah |
Granule | Granule wax yar ka brown ah oo midab kareem ah | Granule wax yar ka brown ah oo midab kareem ah | Granule wax yar ka brown ah oo midab kareem ah | |
Aqoonsiga | ———— | waafaqsan | ———— | |
Tijaabooyin | Dufanka ku jira | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Luminta qalajinta | ≤5.0% 105℃, 4saac | ≤ 5.0% 670Pa 60℃, 4saac | ≤ 5.0% Ku qallaji Vacuum 60℃, 4saac | |
Walxaha haraaga ah | ———— | ≤ 0.5% Marka loo eego EP(5.4) | ≤ 0.5% Marka loo eego USP(467) | |
Cabbirka walxaha | ———— | Marka loo eego EP (2.1.4&2.9.12) | Marka loo eego USP(811) | |
Qiimayn | Protease | ≥600U/g | 1.0~5.2Ph.Eur.U/mg | 100~450USP.U/mg |
Amylase | ≥7000U/g | 12.0~80.0Ph.Eur.U/mg | 100 ~ 500USP.U/mg | |
Lipase | ≥4000U/g | 15.0~130Ph.Eur.U/mg | 10~90USP.U/mg | |
Waxyeellada Microbial | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan | waafaqsan |
Xigasho degdeg ah oo wanaagsan, la-taliyayaal xog-ogaal ah si ay kaaga caawiyaan inaad doorato badeecada saxda ah ee ku habboon dhammaan baahiyahaaga, waqti wax-soo-saar gaaban, koontarool tayo leh oo mas'uul ah iyo adeegyo kala duwan oo ku saabsan bixinta iyo dhoofinta arrimaha warshadda qiimaha jaban ee Fasalka Warshadaha Pancreatin ee Qalab Ceyriin ah oo dheefshiidka leh Shahaadada GMP , Waxaan ku dadaali doonaa inaan la kulano ama dhaafno baahida macaamiisha alaab tayo wanaagsan leh, fikrad horumarsan, iyo shirkad guul iyo waqti ku habboon.Waxaan soo dhawaynaynaa dhammaan macaamiisha.
warshad qiimo jabanShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada DheefshiidkaShirkaddayadu waxay sii wadi doontaa inay u hoggaansanto "tayada sare, sumcadda, adeegsadaha marka hore" si daacad ah.Waxaan si diiran u soo dhawaynaynaa saaxiibo ka kala socda qaybaha kala duwan ee nolosha si ay u soo booqdaan oo ay u bixiyaan hagitaan, wada shaqeeyaan oo ay abuuraan mustaqbal ifaya!