Iyada oo la adeegsanayo tikniyoolajiyada horumarsan iyo tas-hiilaadka, gacan-qabsiga tayada sare leh, heerka macquulka ah, adeegyada sare iyo iskaashiga dhow ee rajada, waxaan u heellannahay inaan u soo bandhigno qiimaha ugu fiican macaamiisheenna Warshada Shahaado, Ku soo dhawoow mid ka mid ah su'aalaha iyo walaacyada ku saabsan alaabtayada, waxaan rajeyneynaa inaan abuurno guur ganacsi oo waqti dheer ah adiga iyo adiga inta lagu jiro mustaqbalka fog.maanta na soo wac.
Iyada oo la adeegsanayo tignoolajiyada horumarsan iyo tas-hiilaadka, gacan-qabsiga tayada sare leh, qiime macquul ah, adeegyo heersare ah iyo iskaashi dhow oo lala yeesho rajada, waxaan u heellannahay inaan u soo bandhigno qiimaha ugu fiican ee macaamiisheenaShiinaha Pancreatic Enzyme Budada Pancreatin, Budada Enzyme Pancreatic Dheefshiidka, Xakamaynta tayada adag ayaa lagu fuliyay xiriir kasta oo ka mid ah geeddi-socodka wax-soo-saarka oo dhan. Waxaan si dhab ah u rajaynaynaa inaan aasaasno iskaashiga saaxiibtinimo iyo faa'iido-wadaaga adiga kula leh.Iyada oo ku saleysan baayacmushtar tayo sare leh iyo adeeg iibka ka dib oo kaamil ah waa fikradeena, macaamiisha qaar ayaa nala shaqaynayay in ka badan 5 sano.
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 |
Iyada oo la adeegsanayo tikniyoolajiyada horumarsan iyo tas-hiilaadka, gacan-qabsiga tayada sare leh, heerka macquulka ah, adeegyada sare iyo iskaashiga dhow ee rajada, waxaan u heellannahay inaan u soo bandhigno qiimaha ugu fiican macaamiisheenna Warshada Shahaado, Ku soo dhawoow mid ka mid ah su'aalaha iyo walaacyada ku saabsan alaabtayada, waxaan rajeyneynaa inaan abuurno guur ganacsi oo waqti dheer ah adiga iyo adiga inta lagu jiro mustaqbalka fog.maanta na soo wac.
Warshada si toos ah u keenShiinaha Pancreatic Enzyme Budada Pancreatin, Budada Enzyme Pancreatic Dheefshiidka, Xakamaynta tayada adag ayaa lagu fuliyay xiriir kasta oo ka mid ah geeddi-socodka wax-soo-saarka oo dhan. Waxaan si dhab ah u rajaynaynaa inaan aasaasno iskaashiga saaxiibtinimo iyo faa'iido-wadaaga adiga kula leh.Iyada oo ku saleysan baayacmushtar tayo sare leh iyo adeeg iibka ka dib oo kaamil ah waa fikradeena, macaamiisha qaar ayaa nala shaqaynayay in ka badan 5 sano.