Waxaan haynaa qalab casri ah.Alaabadayada waxaa loo dhoofiyaa USA, UK iyo wixii la mid ah, adigoo ku raaxaysanaya sumcad wanaagsan oo macaamiisha ah ee Pancreatin Jumlad, Haddii aad raacdo tayada Hi-tayada, Hi-stable, qaybaha qiimaha gardarrada, magaca ganacsiga ayaa ah doorashadaada ugu waxtarka badan!
Waxaan haynaa qalab casri ah.Alaabadayada waxaa loo dhoofiyaa USA, UK iyo wixii la mid ah, anagoo ku raaxaysanayna sumcad wanaagsan macaamiisha dhexdoodaShiinaha Pancreatin iyo Pepsin, Kooxdayada injineernimada khabiirada guud ahaan waxay u diyaar garoobi doonaan inay kuu adeegaan la tashi iyo jawaab celin.Waxaan sidoo kale ku siin karnaa muunado lacag la'aan ah si aad u buuxiso shuruudahaaga.Dadaallada ugu wanaagsan waxay u badan tahay in la soo saari doono si laguu siiyo adeegga iyo badeecada ugu fiican.Marka aad xiisaynayso ganacsigeena iyo alaabtayada, iska hubi inaad nala hadasho adiga oo ii soo diraya iimaylo ama si degdeg ah noogu soo wac.Dadaal lagu ogaanayo badeecadayada iyo shirkadeena dheeraadka ah, waxaad u iman kartaa warshadeena si aad u aragto.Waxaan guud ahaan ku soo dhawaynaynaa martida aduunka oo dhan si ay ganacsigeena noogu abuuraan xidhiidh ganacsi.Hubi inaad dareento lacag la'aan si aad noola hadasho ganacsiyada yaryar waxaanan aaminsanahay inaan la wadaagi doono khibrada ganacsi ee ugu fiican dhammaan baayacmushtarkeena.
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 |
Waxaan haynaa qalab casri ah.Alaabadayada waxaa loo dhoofiyaa USA, UK iyo wixii la mid ah, adigoo ku raaxaysanaya sumcad wanaagsan oo macaamiisha ah ee Pancreatin Jumlad, Haddii aad raacdo tayada Hi-tayada, Hi-stable, qaybaha qiimaha gardarrada, magaca ganacsiga ayaa ah doorashadaada ugu waxtarka badan!
JumloShiinaha Pancreatin iyo Pepsin, Kooxdayada injineernimada khabiirada guud ahaan waxay u diyaar garoobi doonaan inay kuu adeegaan la tashi iyo jawaab celin.Waxaan sidoo kale ku siin karnaa muunado lacag la'aan ah si aad u buuxiso shuruudahaaga.Dadaallada ugu wanaagsan waxay u badan tahay in la soo saari doono si laguu siiyo adeegga iyo badeecada ugu fiican.Marka aad xiisaynayso ganacsigeena iyo alaabtayada, iska hubi inaad nala hadasho adiga oo ii soo diraya iimaylo ama si degdeg ah noogu soo wac.Dadaal lagu ogaanayo badeecadayada iyo shirkadeena dheeraadka ah, waxaad u iman kartaa warshadeena si aad u aragto.Waxaan guud ahaan ku soo dhawaynaynaa martida aduunka oo dhan si ay ganacsigeena noogu abuuraan xidhiidh ganacsi.Hubi inaad dareento lacag la'aan si aad noola hadasho ganacsiyada yaryar waxaanan aaminsanahay inaan la wadaagi doono khibrada ganacsi ee ugu fiican dhammaan baayacmushtarkeena.