Ngwaahịa
Pancreatin nke Deebio nwere nhazi ntụ ntụ, granule na pellet
Nkọwa
1. Ihe odide: Pancreatin bụ obere aja aja, ntụ ntụ amorphous ma ọ bụ obere aja aja na granule na-acha ude.Ọ mejupụtara amylase, lipase na protease.
2. Isi iyi: Porcine pancreas.
Usoro 3.: A na-ewepụta Pancreatin na pancreatin dị mma site na teknụzụ mwepu-mwepu nke anyị.
4 .Ngosipụta na ojiji: Pancreatin bụ ngwakọta nke ọtụtụ enzymes digestive nke pancreas na-emepụta.Enwere ike iji ya na ụlọ ọrụ ọgwụ, nhazi nri, tanning, ịsacha na mpaghara ndị ọzọ, yana ngwa ngwa dị iche iche.
Gịnị mere anyị?
· Emepụtara na ogbako GMP
· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D
· A na-achọpụta ihe ọkụkụ
· Soro ọkọlọtọ ndị ahịa
· Mbupụ gaa na mba na mpaghara iri atọ
· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.
Nkọwapụta
| Nnwale ihe | Nkọwapụta ụlọ ọrụ | |||
| CP | EP | USP | ||
| Ndị agwa | Ntụ ntụ | Obere agba aja aja, ntụ ntụ amorphous | Obere agba aja aja, ntụ ntụ amorphous | Obere agba aja aja, ntụ ntụ amorphous |
| Granule | Granule dị ntakịrị aja aja ruo ude | Granule dị ntakịrị aja aja ruo ude | Granule dị ntakịrị aja aja ruo ude | |
| njirimara | ———— | Dabara | ———— | |
| Nnwale | Ọdịnaya abụba | ≤20mg/g | ≤5.0% | ≤3.0% (<3USP);≤ 6.0% (≥3USP) |
| Ọnwụ na ihicha | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Akọrọ na Vacuum 60℃, 4h | |
| Ihe mgbaze fọdụrụnụ | ———— | ≤ 0.5% Dị ka EP (5.4) si kwuo | ≤ 0.5% Dị ka USP (467) si kwuo | |
| Nha urughuru | ———— | Dabere na EP (2.1.4 & 2.9.12) | Dabere na USP (811) | |
| Nyocha | Mgbochi | ≥600U/g | 1.0～5.2 Ph.Eur.U/mg | 100～450USP.U/mg |
| Amylase | ≥7000U/g | 12.0～80.0Ph.Eur.U/mg | 100～500USP.U/mg | |
| Lipase | ≥4000U/g | 15.0～130 Ph.Eur.U/mg | 10～90USP.U/mg | |
| Microbial adịghị ọcha | TAMC | ≤10000cfu/g | ≤10000cfu/g | ≤10000cfu/g |
| TYMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | |
| E.coli | Dabara | Dabara | Dabara | |
| Salmonella | Dabara | Dabara | Dabara | |
