Taasi waxay leedahay dabeecad togan oo horusocod ah oo soo jiidashada macaamiisha, shirkaddeena waxay si joogto ah u wanaajisaa badeecadeena tayada sare leh si ay u buuxiso baahida macaamiisha waxayna sii dheereysaa amniga, isku halaynta, shuruudaha deegaanka, iyo hal-abuurka Shiinaha ee Tayada Sare ee Iibinta ugu WanaagsanKallidinogenase (CAS: 9001-01-8), Caadi ahaan inta badan isticmaalayaasha ganacsiga iyo ganacsatada si ay u bixiyaan alaab tayo wanaagsan leh iyo shirkad heer sare ah.Si diiran ugu soo dhawoow inaad nagu soo biirto, aynu hal-abuur u samayno si wadajir ah, si aynu riyo u duulno.
Taas oo leh dabeecad togan oo horusocod leh oo soo jiidashada macaamiisha ah, shirkaddeenu waxay si joogto ah u wanaajisaa badeecadeena tayada sare leh si ay u buuxiso baahida macaamiisha waxayna sii dheereysaa amniga, isku halaynta, shuruudaha deegaanka, iyo hal-abuurnimadaKallidinogenas, Waxaan ujeedadeedu tahay inaan noqono shirkad casri ah oo leh fikrad ganacsi oo ah "Daacadnimo iyo Kalsooni" iyo ujeeddada "Soo bixinta macaamiisha adeegyada ugu daacadsan iyo alaabta tayada ugu fiican".Waxaan si daacad ah u waydiisanaynaa taageeradaada aan isbeddelin waxaanan ku mahad naqaynaa taladaada iyo tusaalahaaga naxariista leh.
1. Characters: Caddaan ama ku dhawaad budo cad, oo aan ur lahayn.
2. Isha Soosaarka: Beeryarada Porcine.
3. Habka: Kallidinogenase waxaa laga soo saaraa beeryarada doofaarka ee caafimaadka leh.
4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa loo isticmaali karaa noocyo kala duwan oo ah cudurrada wadnaha iyo xididdada dhiigga, sida cudurada wadnaha, arteriosclerosis maskaxda, thrombosis cerebral thrombosis, cilladaha sahayda dhiigga retinal iyo cudurrada xididdada durugsan.Saameyn daweyn oo wanaagsan ku yeelata cilmi-baarisyadii ugu dambeeyay ee ka hortagga hore ee microangiopathy macaanka iyo nephropathy macaanka, waxay yareyn kartaa soosaarka albumin-ka.Xogta caafimaad ee gudaha iyo dibaddaba waxay soo jeedinaysaa in ay kordhin karto dhaqdhaqaaqa shahwada iyo tirada wax-soo-saarka, oo ay leedahay saamayn dawo ah oo lagu daweynayo qaar ka mid ah madhalaysnimada ragga.
Waxa lagu soo saaray aqoon-is-weydaarsiga GMP
· 27 sano oo enzyme noole R&D taariikhda
Walxaha ceeriin waa la raadin karaa
U hoggaansamaan heerka macaamiisha
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | ||
CP | JP | ||
Jilayaasha | Caddaan ama ku dhawaad cad cad, oo aan ur lahayn | Caddaan ilaa budo yar oo bunni ah, aan ur lahayn ama ay daciif tahay | |
Aqoonsiga | R (Heerka Hydrolysis): 0.12~0.17 | R (Heerka Hydrolysis): 0.12~0.16 | |
Chromatography dareere: Waafaqsan | I: ≤ 0.2 | ||
Tijaabooyin | pH | 5.5-7.5 (300 unug/ml) | 5.5-7.5 (1g/300ml) |
Caddayn xalka | Nadiifi (2mg/ml) | ———— | |
Baruur | ≤ 5.0mg/g | ≤ 1.0mg/g | |
Kininase | ———— | R Qiimaha: ≥ 0.8 | |
Maado u eg Trypsin | ———— | Qiimaha T: ≤ 0.05 | |
Protease | A280≤ 0.2 | A280≤ 0.2 | |
Luminta qalajinta | ≤ 5.0% (60℃ Vacuum ku qallalan, 4 saac) | ≤ 2.0% (60℃ Vacuum ku qallalan, 4 saac) | |
Hadhaaga dabka | ≤ 3.0% | ≤ 3.0% | |
Kinin-sii daynta hawsha | ———— | ≥ 500ng bradykinin u dhiganta/min/cutubkiiba | |
daahirnimo | ≥ 75% (afka ah) | ———— | |
≥ 90% (durida) | |||
Bakteeriyada endotoxin | ≤ 2.5 EU/cutub (ku duritaan) | ———— | |
Qiimayn | Dhaqdhaqaaqa enzyme | ———— | ≥ 25 halbeeg/mg |
Dhaqdhaqaaq gaar ah | ≥ 300 unug/mg borotiin (oo afka ah) | ≥ 100 unug/mg borotiin | |
≥ 600 unug/mg borotiin (ku duritaan) | |||
Waxyeellada Microbial | TAMC | ≤ 1000cfu/g (afka ah) | ≤ 1000cfu/g |
≤ 100cfu/g (duritaan) | |||
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan |
Taasi waxay leedahay dabeecad togan oo horusocod leh oo soo jiidashada macaamiisha ah, ganacsigeenu wuxuu si joogto ah u wanaajiyaa badeecada tayada sare leh si uu u daboolo baahida macaamiisha wuxuuna sii dheereeyaa badbaadada, isku halaynta, shuruudaha deegaanka, iyo hal-abuurka Shiinaha ee Tayada Sare ee Kallidinogenase (CAS: 9001-01-8), Caadi ahaan inta badan isticmaalayaasha ganacsiga iyo ganacsatada si ay u bixiyaan alaabo tayo wanaagsan leh iyo shirkad heer sare ah.Si diiran ugu soo dhawoow inaad nagu soo biirto, aynu hal-abuur u samayno si wadajir ah, si aynu riyo u duulno.
Iibinta ugu Wanaagsan ee China Pharmaceutical Intermediate, Antibiyootiga, Waxaan ujeedadeedu tahay inaan noqono shirkad casri ah oo leh fikrad ganacsi oo ah "Daacadnimo iyo Kalsooni" iyo ujeeddada "Siinta macaamiisha adeegyada ugu daacadsan iyo alaabta tayada ugu fiican".Waxaan si daacad ah u waydiisanaynaa taageeradaada aan isbeddelin waxaanan ku mahad naqaynaa taladaada iyo tusaalahaaga naxariista leh.