Feme ea rona e tsepamisitse maikutlo holim'a leano la brand.Khotsofalo ea bareki ke papatso ea rona e ntle ka ho fetisisa.Re boetse re fana ka mofani oa OEM bakeng sa phano e potlakileng ea China ChemicalsHeparin sodium, Ntlafatso e sa feleng le ho loanela ho haella ha 0% ke maano a rona a mabeli a mantlha a boleng.Haeba u hloka eng kapa eng, u se ke oa tsilatsila ho ikopanya le rona.
Feme ea rona e tsepamisitse maikutlo holim'a leano la brand.Khotsofalo ea bareki ke papatso ea rona e ntle ka ho fetisisa.Re boetse re fana ka mofani oa OEM bakeng saHeparin sodium, Re lumela boleng le khotsofalo ea bareki e fihletsoeng ke sehlopha sa batho ba inehetseng haholo.Sehlopha sa k'hamphani ea rona se sebelisang mahlale a morao-rao se fana ka thepa ea boleng bo holimo e ratoang le ho ananeloa ke bareki ba rona lefatšeng ka bophara.
1. Litlhaku: Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo.
2. Mohloli: Mucosa ea mala a kolobe.
3. Ts'ebetso: Sodium ea Heparin e ntšoa ho tswa ho porcine intestine mucosa e phetseng hantle.
4. Lipontšo le tšebeliso: Sehlahisoa sena se sebelisoa haholo-holo bakeng sa thibelo ea lefu la thromboembolic, haholo-holo e loketseng tlhokahalo ea anticoagulant ka potlako, e kang: 1. Acute or chronic venous thrombosis kapa ha ho na phetoho e matla ea phallo ea mali ea pulmonary embolism (PE) .Heparin e ka emisa katoloso ea embolus ho ipha nako ea thrombolysis ea 'mele e itlelang feela.2. Thibelo le kalafo ea Atrial fibrillation ka embolism.3. Kalafo ea pele ea diffuse intravascular coagulation(DIC).4. Thibelo le kalafo ea peripheral arterial thrombosis kapa myocardial infarction.5. Anticoagulation e 'ngoe ea in vitro: joalo ka opereishene ea pelo, potoloho ea mali, hemodialysis, angiography, le eona e ka sebelisoa bakeng sa tšelo ea mali kapa tokiso ea mohlala oa mali, hajoale matšoao a mantlha a tšebeliso ea heparin ke deep vein thrombosis(DVT), PE le thrombosis. ho bakuli ba kotsing e kholo.
· E fetisitse Chinese GMP
· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D
· Lisebelisuoa tse tala lia lateloa
·Ho lumellana le USP、EP le maemo a bareki
· Romella kantle ho naha le libakeng tse fetang 30
·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.
Lintho tsa Tlhahlobo | Tlhaloso ea Khampani | ||
EP | USP | ||
Litlhaku | Phofo e tšoeu kapa e batlang e le tšoeu, e nang le hygroscopic haholo | ||
Boitsebiso | Thrombotest: E lumellana | Boitsebiso ba Chromatographic: Bo lumellana | |
1H NMR Spectrum: E lumellana | 1H NMR Spectrum: E lumellana | ||
Liquid Chromatography: E lumellana | Boima ba boima ba 'mele: 15000 ~ 19000 | ||
Sodium: E lumellana | Sodium: E lumellana | ||
Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1 | Anti-factor Xa to anti-factor IIa ratio:0.9 ~ 1.1 | ||
Liteko | Ho hlaka le mmala | Ho hlaka: Ho hlakile, Mmala: ka 5 kapa ho feta | ———— |
Naetrojene | 1.5-2.5% (ntho e omileng) | 1.3 - 2.5% (ntho e omileng) | |
Litšila tsa Nucleotidic | A260≤ 0.15(4mg/ml) | ≤ 0.1 (w/w) | |
Lintho tse amanang | E lumellana | ———— | |
Moeli oa galactosamine ka kakaretso ea hexosamine | ———— | ≤ 1.0% | |
Oversulfate chondroitin sulfate | ———— | E lumellana | |
pH | 5.5–8.0(1%) | 5.5 -7.5 (1%) | |
Tahlehelo ka ho omisa | ≤ 8.0% (60℃ Dry in Vacuum, 3h) | ≤ 5.0% (60℃ Dry in Vacuum, 3h) | |
Masalla ha a tuka | ———— | 28.0% ~41.0% | |
Endotoxin ea baktheria | ≤ 0.01 IU/Setsi sa Machaba sa Heparin | ≤ 0.03 USP U / International Unit ea Heparin | |
Tšepe e boima | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5 ~ 13.5% (ntho e omileng) | ———— | |
Liprotheine | ≤ 0.5% (ntho e omileng) | ≤ 0.1% (karolelano ea boima ba 'mele) | |
Ketsahalo | ≥ 180 IU/mg (ntho e omileng) | ≥ 180 USP U/mg (ntho e omileng) | |
Litšila tsa Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | E lumellana | E lumellana | |
Staphylococcus aureus | E lumellana | E lumellana | |
Salmonella | E lumellana | E lumellana |
Feme ea rona e tsepamisitse maikutlo holim'a leano la brand.Khotsofalo ea bareki ke papatso ea rona e ntle ka ho fetisisa.Re boetse re fana ka mofani oa OEM bakeng sa phano e potlakileng ea China Chemicals Heparin Sodium, Ntlafatso e sa feleng le ho loanela ho haella ha 0% ke maano a rona a mabeli a mantlha a boleng.Haeba u hloka eng kapa eng, u se ke oa tsilatsila ho ikopanya le rona.
Phano e potlakileng ea China Anticoagulant, Pharmaceutical Intermediates, Re lumela boleng le khotsofalo ea bareki e fihlelletsoeng ke sehlopha sa batho ba inehetseng haholo.Sehlopha sa k'hamphani ea rona se sebelisang mahlale a morao-rao se fana ka thepa ea boleng bo holimo e ratoang le ho ananeloa ke bareki ba rona lefatšeng ka bophara.