Ukugxila kwethu kukho kufanele kube ukuhlanganisa kanye nokuthuthukisa ikhwalithi kanye nokulungiswa kwemikhiqizo yamanje, okwamanje hlala sisungula imikhiqizo emisha ukuze ihlangabezane nezidingo zamakhasimende ezihlukile zeFactory Ukunikezela Ngokuqondile i-China Purity Raw Material Pancreatin/I-Pancreatic Enzyme/Izithako ze-Pharma Ezisebenzayo, Ilebhu Yethu manje “Ilebhu Kazwelonke yobuchwepheshe benjini ye-diesel turbo ” , futhi singabanikazi be-R&D abaqeqeshiwe kanye nesikhungo esiphelele sokuhlola.
Ukugxila kwethu kukho kufanele kube ukuhlanganisa kanye nokuthuthukisa ikhwalithi kanye nokulungiswa kwemikhiqizo yamanje, okwamanje sisungula imikhiqizo emisha ukuhlangabezana nezidingo zamakhasimende ahlukileI-Pancreatin yaseChina, I-Pancreatic Enzyme, Zonke izimpahla zethu zithunyelwa kumakhasimende ase-UK, Germany, France, Spain, USA, Canada, Iran, Iraq, Middle East nase-Afrika.Imikhiqizo yethu nezixazululo zamukelwa kahle amakhasimende ethu ngekhwalithi ephezulu, amanani ancintisanayo kanye nezitayela ezivumayo kakhulu.Sithemba ukusungula ubudlelwano bebhizinisi nawo wonke amakhasimende futhi silethe imibala eminingi emihle empilweni yakho yonke.
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 |
Sinikezela NgokuqondileI-Pancreatin yaseChina, I-Pancreatic Enzyme, Zonke izimpahla zethu zithunyelwa kumakhasimende ase-UK, Germany, France, Spain, USA, Canada, Iran, Iraq, Middle East nase-Afrika.Imikhiqizo yethu nezixazululo zamukelwa kahle amakhasimende ethu ngekhwalithi ephezulu, amanani ancintisanayo kanye nezitayela ezivumayo kakhulu.Sithemba ukusungula ubudlelwano bebhizinisi nawo wonke amakhasimende futhi silethe imibala eminingi emihle empilweni yakho yonke.