Ugxininiso lwethu kufuneka lube kukuhlanganisa kunye nokuphucula umgangatho kunye nokulungiswa kweemveliso zangoku, okwangoku sihlala siseka iimveliso ezintsha ukuhlangabezana neemfuno zabathengi abakhethekileyo kwiFactory Ukubonelela ngokuthe ngqo iChina Purity Raw Material Pancreatin/I-Pancreatic Enzyme/Izithako ze-Pharma eziSebenzayo, iLebhu yethu ngoku “yiLebhu yeSizwe ye-turbo ye-injini ye-diesel ” , kwaye singabasebenzi abaqeqeshiweyo be-R&D kunye neziko lovavanyo elipheleleyo.
Ugxininiso lwethu kufuneka lube kukuhlanganisa kunye nokuphucula umgangatho kunye nokulungiswa kweemveliso zangoku, okwangoku sihlala siseka iimveliso ezintsha ukuhlangabezana neemfuno zabathengi abakhethekileyoPancreatin yaseTshayina, I-Pancreatic Enzyme, Zonke iimpahla zethu zithunyelwa kumazwe angaphandle kubathengi base-UK, eJamani, eFransi, eSpain, e-USA, eKhanada, e-Iran, e-Iraq, kuMbindi Mpuma nase-Afrika.Iimveliso zethu kunye nezisombululo zamkelwe kakuhle ngabaxumi bethu ngomgangatho ophezulu, amaxabiso akhuphisanayo kunye nezona ndlela zilungileyo.Sinethemba lokuseka ubudlelwane beshishini nabo bonke abathengi kwaye sizise imibala emihle ngakumbi ebomini.
1. Abalinganiswa: I-Pancreatin ngumgubo kancinane omdaka, o-amorphous okanye umdaka kancinci ukuya kwigranule enombala okhrimu.Iqulethwe yi-amylase, i-lipase kunye ne-protease.
2. Ukukhutshwa Umthombo: Ipancreas yehagu.
3. Inkqubo: I-Pancreatin itsalwa kwi-pancreas enempilo ye-porcine ngeteknoloji yethu yokukhupha iteknoloji ekhethekileyo.
4 .Izibonakaliso kunye nokusetyenziswa: I-Pancreatin ngumxube wee-enzyme ezininzi zokugaya eziveliswa yi-pancreas ye-porcine.Ingasetyenziswa kwishishini lamachiza, ukusetyenzwa kokutya, ukuthambisa, ukuhlamba kunye nezinye iindawo, ezinoluhlu olubanzi lwezicelo.
·Iveliswe kwiworkshop yeGMP
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela umgangatho wabathengi
·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla
·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.
Izinto zovavanyo | Inkcazo yeNkampani | |||
CP | EP | USP | ||
Abalinganiswa | Umgubo | Umgubo kancinane omdaka, oneamorphous | Umgubo kancinane omdaka, oneamorphous | Umgubo kancinane omdaka, oneamorphous |
Igranule | Igranule emdaka kancinci ukuya kumbala wekhrim | Igranule emdaka kancinci ukuya kumbala wekhrim | Igranule emdaka kancinci ukuya kumbala wekhrim | |
Ukuchongwa | ———— | Iyahambelana | ———— | |
Iimvavanyo | Umxholo wamafutha | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Ilahleko ekomisweni | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Yomile kwiVacuum 60℃, 4h | |
Isinyibilikisi esishiyekileyo | ———— | ≤ 0.5% Ngokungqinelana ne-EP(5.4) | ≤ 0.5%Ngokungqinelana ne-USP(467) | |
Ubungakanani besuntswana | ———— | Ngokwe-EP(2.1.4&2.9.12) | Ngokutsho kweUSP(811) | |
Isivavanyi | Iprotease | ≥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 | |
Ukungcola kweMicrobial | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Iyahambelana | Iyahambelana | Iyahambelana | |
Salmonella | Iyahambelana | Iyahambelana | Iyahambelana |
Sinikezela ngokuthe ngqoPancreatin yaseTshayina, I-Pancreatic Enzyme, Zonke iimpahla zethu zithunyelwa kumazwe angaphandle kubathengi base-UK, eJamani, eFransi, eSpain, e-USA, eKhanada, e-Iran, e-Iraq, kuMbindi Mpuma nase-Afrika.Iimveliso zethu kunye nezisombululo zamkelwe kakuhle ngabaxumi bethu ngomgangatho ophezulu, amaxabiso akhuphisanayo kunye nezona ndlela zilungileyo.Sinethemba lokuseka ubudlelwane beshishini nabo bonke abathengi kwaye sizise imibala emihle ngakumbi ebomini.