Mehaho ea rona e nang le thepa e ntle le taolo ea boleng bo botle methating eohle ea tlhahiso e re thusa ho netefatsa khotsofalo e felletseng ea bareki bakeng sa theolelo e kholo ea Pharmaceutical Raw Materials Powder Pancreatin CAS 8049-47-6, Re ts'episa ho leka ka matla ho u lopolla ka boleng bo holimo le bo phahameng. lihlahisoa tsa moruo le litšebeletso.
Mehaho ea rona e nang le thepa e ntle le taolo ea boleng bo holimo methating eohle ea tlhahiso e re thusa ho netefatsa khotsofalo e felletseng ea bareki bakeng saChina Pancreatin le Pancreatin Powder, Khamphani ea rona e sebetsa ho latela molao-motheo oa ts'ebetso ea "tšebelisano-'moho e thehiloeng ho bots'epehi, tšebelisano-'moho, e ikemiselitseng batho, tšebelisano-'moho ea katleho".Re tšepa hore re ka ba le likamano tsa botsoalle le mohoebi ea tsoang lefats'eng lohle.
1. Litlhaku: Pancreatin ke phofshoana e sootho hanyane, ea amorphous kapa e sootho hanyane ho isa ho granule ea 'mala oa tranelate.E entsoe ka amylase, lipase le protease.
2. Mohloli oa Mohloli: Li-pancreas tsa Porcine.
3. Ts'ebetso: Pancreatin e ntšoa ho li-pancreas tse phetseng hantle ka theknoloji ea rona e ikhethileng ea ho ntša.
4 .Lipontšo le tšebeliso: Pancreatin ke motsoako oa li-enzyme tse ngata tsa tšilo tse hlahisoang ke manyeme a porcine.E ka sebelisoa indastering ea meriana, ho lokisa lijo, ho suha matlalo, ho hlatsoa le masimo a mang, ka mefuta e mengata ea lits'ebetso.
·E hlahisoa ka har'a workshop ea GMP
· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D
· Lisebelisuoa tse tala lia lateloa
·Latela maemo a bareki
· Romella kantle ho naha le libakeng tse fetang 30
·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.
Lintho tsa Tlhahlobo | Tlhaloso ea Khampani | |||
CP | EP | USP | ||
Litlhaku | Phofo | Phofo e sootho hanyane, ea amorphous | Phofo e sootho hanyane, ea amorphous | Phofo e sootho hanyane, ea amorphous |
Granule | Granule e sootho hanyane ho isa ho tranelate | Granule e sootho hanyane ho isa ho tranelate | Granule e sootho hanyane ho isa ho tranelate | |
Boitsebiso | ———— | E lumellana | ———— | |
Liteko | Mafura a mafura | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Tahlehelo ka ho omisa | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0%Dry in Vacuum 60℃, 4h | |
Mokelikeli o setseng | ———— | ≤ 0.5% Ho latela EP(5.4) | ≤ 0.5% Ho latela USP(467) | |
Boholo ba likaroloana | ———— | Ho latela EP(2.1.4&2.9.12) | Ho latela USP(811) | |
Tlhahlobo | 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 | |
Litšila tsa Microbial | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | E lumellana | E lumellana | E lumellana | |
Salmonella | E lumellana | E lumellana | E lumellana |
Mehaho ea rona e nang le thepa e ntle le taolo ea boleng bo botle methating eohle ea tlhahiso e re thusa ho netefatsa khotsofalo e felletseng ea bareki bakeng sa theolelo e kholo ea Pharmaceutical Raw Materials Powder Pancreatin CAS 8049-47-6, Re ts'episa ho leka ka matla ho u lopolla ka boleng bo holimo le bo phahameng. lihlahisoa tsa moruo le litšebeletso.
Theko e kholoChina Pancreatin le Pancreatin Powder, Khamphani ea rona e sebetsa ho latela molao-motheo oa ts'ebetso ea "tšebelisano-'moho e thehiloeng ho bots'epehi, tšebelisano-'moho, e ikemiselitseng batho, tšebelisano-'moho ea katleho".Re tšepa hore re ka ba le likamano tsa botsoalle le mohoebi ea tsoang lefats'eng lohle.