Re motlotlo ka thabo e kholo ea bareki le kamohelo e pharaletseng ka lebaka la ho phehella ha rona ho phehella holimo ho mefuta e 'ngoe le e' ngoe mabapi le tharollo le tokiso ea boleng bo phahameng ba China Pharmaceutical CAS 679809-58-6Enoxaparin sodiumAntiviral Enoxaparin Sodium Enoxaparin, Re tsoa ho baetsi ba kholo ka ho fetisisa ba 100% Chaena.Likhoebo tse ngata tse kholo li reka thepa ho tsoa ho rona, kahoo re tla u fa tekete ea theko e sebetsang ka ho fetisisa e nang le boleng bo ts'oanang haeba u na le thahasello ho rona.
Re motlotlo ka thabo e kholo ea bareki le kamohelo e pharaletseng ka lebaka la ho phehella ha rona ho phehella maemo a holimo ka ho fetisisa ka tharollo le ho lokisoa.Enoxaparin ea China, Enoxaparin sodium, Taolo e tiileng ea boleng e etsoa khokahanyong e 'ngoe le e' ngoe ea ts'ebetso eohle ea tlhahiso.Re tšepa ka tieo ho theha tšebelisano-'moho e nang le botsoalle le e molemo ka bobeli le uena.Ho ipapisitsoe le thepa ea boleng bo holimo le tšebeletso e phethahetseng ea pele ho thekiso / kamora thekiso ke mohopolo oa rona, bareki ba bang ba sebelisane le rona ka lilemo tse fetang 5.
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 |
Re motlotlo ka thabo e kholo ea moreki le kamohelo e pharaletseng ka lebaka la ho phehella ha rona ho phehella maemo a holimo ho mefuta e 'ngoe le e' ngoe mabapi le tharollo le tokiso ea boleng bo holimo China Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, Re ba bang ba kholo ka ho fetisisa 100% baetsi ba Chaena.Likhoebo tse ngata tse kholo li reka thepa ho tsoa ho rona, kahoo re tla u fa tekete ea theko e sebetsang ka ho fetisisa e nang le boleng bo ts'oanang haeba u na le thahasello ho rona.
Boleng bo phahamengEnoxaparin ea China, Enoxaparin Sodium, taolo e thata ea boleng e etsoa selekaneng se seng le se seng sa ts'ebetso eohle ea tlhahiso.Ho ipapisitsoe le thepa ea boleng bo holimo le tšebeletso e phethahetseng ea pele ho thekiso / kamora thekiso ke mohopolo oa rona, bareki ba bang ba sebelisane le rona ka lilemo tse fetang 5.