Besizibophezele ekunikezeni inani elinamandla, izimpahla ezisezingeni eliphakeme, ngokufanayo nokulethwa okusheshayo Kwekhwalithi Ephezulu Yekhwalithi Ephezulu ye-Pancreatin 8049-47-6 Ngenani Elizwakalayo Lomkhiqizo Wesitifiketi Se-GMP, intengo yokuthengisa enolaka enekhwalithi ephezulu kanye nezinsizakalo ezigculisayo zisenza sizuze. abathengi abaningi kakhulu.sifisa ukusebenza nawe futhi sibheke ukuthuthukiswa okufanayo.
Besilokhu sizibophezele ekunikezeni inani elinamandla, izimpahla ezihlukile zekhwalithi enhle, ngokufanayo nokulethwa okusheshayoI-China Pancreatin kanye ne-8049-47-6, Besilokhu sinweba imakethe ngaphakathi kwe-Romania ngokungeziwe ekulungiseleleni ukuthengisa ngekhwalithi eyengeziwe yekhwalithi ephezulu exhunywe nephrinta kwi-t shirt ukuze ukwazi e-Romania.Abantu abaningi bakholelwa ngokuqinile ukuthi sinawo wonke amandla okukunikeza izixazululo ezijabulisayo.
1. Izinhlamvu: I-Pancreatin iyimpushana ensundu kancane, e-amorphous noma insundu kancane ukuya kugranule enombala kakhilimu.Yakhiwa i-amylase, i-lipase ne-protease.
2. Ukukhipha Umthombo: Amanyikwe engulube.
3. inqubo: I-Pancreatin ikhishwa kuma-pancreas enempilo ngobuchwepheshe bethu obukhethekile bokukhipha.
4 .Izinkomba kanye nokusetshenziswa: I-Pancreatin iyingxube yama-enzyme amaningana okugaya akhiqizwa amanyikwe engulube.Ingasetshenziswa embonini yezemithi, ukucutshungulwa kokudla, ukushuka, ukuwasha neminye imikhakha, enezinhlelo eziningi ezahlukene.
·Kwenziwe ku-workshop ye-GMP
·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D
·Izinto ezingavuthiwe ziyalandeleka
·Thobela izinga lamakhasimende
·Thumela emazweni nasezifundeni ezingaphezu kuka-30
·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.
Izinto Zokuhlola | Ukucaciswa Kwenkampani | |||
CP | EP | USP | ||
Izinhlamvu | Impushana | Impushana ensundu kancane, e-amorphous | Impushana ensundu kancane, e-amorphous | Impushana ensundu kancane, e-amorphous |
I-Granule | Igranule enombala onsundu kancane ukuya kokhilimu | Igranule enombala onsundu kancane ukuya kokhilimu | Igranule enombala onsundu kancane ukuya kokhilimu | |
Ukuhlonza | ———— | Kuyavumelana | ———— | |
Izivivinyo | Okuqukethwe kwamafutha | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Ukulahlekelwa ekomisweni | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0%Yomisa ku-Vacuum 60℃, 4h | |
I-solvent eyinsalela | ———— | ≤ 0.5%Ngokuya nge-EP(5.4) | ≤ 0.5%Ngokuya nge-USP(467) | |
Usayizi wezinhlayiya | ———— | Ngokusho kwe-EP(2.1.4&2.9.12) | Ngokusho kwe-USP(811) | |
Isivivinyo | I-Protease | ≥600U/g | 1.0–5.2Ph.Eur.U/mg | 100-450USP.U/mg |
I-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 | |
Ukungcola Kwe-Microbial | I-TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Kuyavumelana | Kuyavumelana | Kuyavumelana | |
I-Salmonella | Kuyavumelana | Kuyavumelana | Kuyavumelana |
Besizibophezele ekunikezeni inani elinamandla, izimpahla ezisezingeni eliphakeme, ngokufanayo nokulethwa okusheshayo Kwekhwalithi Ephezulu Yekhwalithi Ephezulu ye-Pancreatin 8049-47-6 Ngenani Elizwakalayo Lomkhiqizo Wesitifiketi Se-GMP, intengo yokuthengisa enolaka enekhwalithi ephezulu kanye nezinsizakalo ezigculisayo zisenza sizuze. abathengi abaningi kakhulu.sifisa ukusebenza nawe futhi sibheke ukuthuthukiswa okufanayo.
Ikhwalithi ephezulu yeI-China Pancreatin kanye ne-8049-47-6, Besilokhu sinweba imakethe ngaphakathi kwe-Romania ngokungeziwe ekulungiseleleni ukuthengisa ngekhwalithi eyengeziwe yekhwalithi ephezulu exhunywe nephrinta kwi-t shirt ukuze ukwazi e-Romania.Abantu abaningi bakholelwa ngokuqinile ukuthi sinawo wonke amandla okukunikeza izixazululo ezijabulisayo.