1. Characters: Caddaan ama ku dhawaad budo cad, aad u hygroscopic.
2. Isha: Xuubabka mindhicirka porcine.
3. Habka: Heparin sodium waxa laga soo saaraa xabka xiidmaha mindhicirka oo caafimaad qaba.
4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa inta badan loo isticmaalaa ka hortagga cudurrada thromboembolic, gaar ahaan ku habboon baahida xinjirowga lidka ku ah si degdeg ah, sida: 1. Dhiig-xinjirow ba'an ama raaga waxay joojin kartaa fidinta embolus si ay waqti ugu hesho xinjirowga dhiigga ee jirka.2. Kahortagga iyo daawaynta fayraska Atrial oo leh embolism.3. Daawaynta hore ee faafinta xinjirowga xididdada dhiigga (DIC).4. Kahortagga iyo daawaynta xinjirowga xididada xididada ama wadna xanuunka myocardial.5. Kuwa kale ee xinjirowga lidka ku ah vitro: sida qalliinka wadnaha iyo xididdada dhiigga, wareegga vitro, hemodialysis, angiography, sidoo kale waxaa loo isticmaali karaa diyaarinta muunada dhiigga, hadda calaamadaha ugu muhiimsan ee codsiga heparin waa xididdada xididdada qotodheer (DVT), PE iyo thrombosis. bukaanada khatarta sare leh.
Wuxuu gudbay GMP-ga Shiinaha
· 27 sano oo enzyme bayooloji R&D taariikhda
Qalabka ceeriin waa la raadin karaa
U hoggaansamaan USP,EPiyo heerka macaamiisha
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maamulka nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.
Walxaha Tijaabada | Tilmaamaha Shirkadda | ||
EP | USP | ||
Jilayaasha | Caddaan ama ku dhawaad cad budo, aad u hygroscopic | ||
Aqoonsiga | Thrombotest: Waa waafaqsan yahay | Aqoonsiga Chromatographic: Waa waafaqsan yahay | |
1H NMR Spectrum: Waa waafaqsan yahay | 1H NMR Spectrum: Waa waafaqsan yahay | ||
Chromatography dareere: Waafaqsan | Celceliska miisaanka-cusub: 15000 ~ 19000 | ||
Sodium: Waafaqsan | Sodium: Waafaqsan | ||
Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1 | Anti-factor Xa ilaa saamiga IIa-ka-hortagga:0.9 ~ 1.1 | ||
Tijaabooyin | Caddayn iyo midab | Cad: Cad, Midab: 5 ama ka sii wanaagsan | ———— |
Nitrojiin | 1.5~2.5%(walax qalalan) | 1.3~2.5%(walax qalalan) | |
wasakhda Nucleotidic | A260≤ 0.15 (4mg/ml) | ≤ 0.1(w/w) | |
Walxaha la xidhiidha | waafaqsan | ———— | |
Xaddid galactosamine guud ahaan hexosamine | ———— | ≤ 1.0% | |
Sulfate chondroitin sulfate | ———— | waafaqsan | |
pH | 5.5~8.0(1%) | 5.5~7.5(1%) | |
Luminta qalajinta | ≤ 8.0%(60℃ Ku qallaji Vacuum, 3h) | ≤ 5.0%(60℃ Ku qallaji Vacuum, 3h) | |
Hadhaaga dabka | ———— | 28.0%~41.0% | |
Bakteeriyada endotoxin | ≤ 0.01 IU/Cutubka Caalamiga ah ee Heparin | ≤ 0.03 USP U/ Unugga Caalamiga ah ee Heparin | |
Bir culus | ≤ 30pm | ≤ 30pm | |
Sodium | 10.5~13.5%(walax qalalan) | ———— | |
Borotiinno | ≤ 0.5%(walax qalalan) | ≤ 0.1%(Saamiga miisaanka) | |
Dhaqdhaqaaqa | ≥ 180 IU/mg(walax qalalan) | ≥ 180 USP U/mg(walax qalalan) | |
wasakhda Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | |
Staphylococcus aureus | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan |