Siyaziqhenya ngenjabulo enkulu yomthengi nokwamukelwa okubanzi ngenxa yokuphikelela kwethu kokuphishekela phezulu kwebanga ngalinye ngesixazululo nokulungisa Ikhwalithi Ephakeme yaseChina Pharmaceutical CAS 679809-58-6I-Enoxaparin SodiumI-Antiviral Enoxaparin Sodium Enoxaparin, Singababakhiqizi abakhulu be-100% baseChina.Izinkampani eziningi ezihwebayo zingenisa izimpahla ezivela kithi, ngakho-ke sizokunikeza ithegi yamanani esebenza kahle kakhulu enayo yonke ikhwalithi efanayo uma unentshisekelo kithi.
Siyaziqhenya ngenjabulo enkulu yomthengi kanye nokwamukelwa okubanzi ngenxa yokuphikelela kwethu kokuphishekela phezulu kwebanga ngalinye ngesixazululo nokulungisaI-Enoxaparin yaseChina, I-Enoxaparin Sodium, Ukulawulwa kwekhwalithi okuqinile kwenziwa kusixhumanisi ngasinye sayo yonke inqubo yokukhiqiza.Sithemba ngobuqotho ukusungula ukubambisana okunobungane nokuzuzisayo nawe.Ngokusekelwe ekuthengisweni kwekhwalithi ephezulu kanye nesevisi ephelele yangaphambi kokuthengisa / ngemva kokuthengisa ingumbono wethu, amanye amaklayenti abesebenzisane nathi iminyaka engaphezu kwemi-5.
1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu.
2. Umthombo: I-porcine intestine mucosa.
3. Inqubo: I-Heparin sodium ikhishwa ku-mucosa yamathumbu e-porcine enempilo.
4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo usetshenziselwa ikakhulukazi ukuvimbela isifo se-thromboembolic, ikakhulukazi esilungele isidingo se-anticoagulant ngokushesha, njengalokhu: 1. I-acute noma engapheli ye-venous thrombosis noma akukho ukugeleza kwegazi okuphawulekayo ushintsho olunamandla lwe-pulmonary embolism(PE).Heparin ingamisa ukunwetshwa kwe-embolus ukwenza isikhathi se-thrombolysis ezenzakalelayo yomzimba.2. Ukuvimbela nokwelashwa kwe-Atrial fibrillation nge-embolism.3. Ukwelashwa kwe-diffuse intravascular coagulation (DIC) yokuqala.4. Ukuvimbela nokwelashwa kwe-peripheral arterial thrombosis noma i-myocardial infarction.5. Enye i-in vitro anticoagulation: njengokuhlinzwa kwenhliziyo nemithambo yegazi, i-in vitro circulation, i-hemodialysis, i-angiography, nayo ingasetshenziselwa ukumpontshelwa noma ukulungiselela isifanekiso segazi, okwamanje izinkomba eziyinhloko zokusetshenziswa kwe-heparin i-deep vein thrombosis(DVT), i-PE kanye ne-thrombosis. ezigulini ezisengozini enkulu.
·Uphumelele i-Chinese GMP
·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D
·Izinto ezingavuthiwe ziyalandeleka
·Thobela i-USP、EP kanye nezinga lekhasimende
·Thumela emazweni nasezifundeni ezingaphezu kuka-30
·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.
Izinto Zokuhlola | Ukucaciswa Kwenkampani | ||
EP | USP | ||
Izinhlamvu | Impushana emhlophe noma ecishe ibe mhlophe, ene-hygroscopic kakhulu | ||
Ukuhlonza | I-Thrombotest: Iyavumelana | Ubunikazi beChromatographic: Kuyavumelana | |
1I-H NMR Spectrum: Iyavumelana | 1I-H NMR Spectrum: Iyavumelana | ||
I-Liquid Chromatography: Iyavumelana | Isisindo-isilinganiso samangqamuzana isisindo: 15000 ~ 19000 | ||
I-Sodium: Iyavumelana | I-Sodium: Iyavumelana | ||
I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1 | I-Anti-factor Xa ukuya ku-anti-factor IIa isilinganiso:0.9~1.1 | ||
Izivivinyo | Ukucaca nombala | Ukucaca: Kucacile, Umbala: ngo-5 noma ngaphezulu | ———— |
I-nitrogen | 1.5-2.5% (into eyomile) | 1.3-2.5% (into eyomile) | |
Ukungcola kwe-Nucleotidic | A260≤ 0.15(4mg/ml) | ≤ 0.1 (w/w) | |
Izinto ezihlobene | Kuyavumelana | ———— | |
Umkhawulo wegalactosamine ku-hexosamine isiyonke | ———— | ≤ 1.0% | |
I-Oversulfate chondroitin sulfate | ———— | Kuyavumelana | |
pH | 5.5-8.0 (1%) | 5.5-7.5 (1%) | |
Ukulahlekelwa ekomisweni | ≤ 8.0% (60℃ Yomisa ku-Vacuum, 3h) | ≤ 5.0% (60℃ Yomisa ku-Vacuum, 3h) | |
Izinsalela ekushiseni | ———— | 28.0%~41.0% | |
I-endotoxin yebhaktheriya | ≤ 0.01 IU/Iyunithi Yamazwe Ngamazwe Ye-Heparin | ≤ 0.03 USP U/Iyunithi Yamazwe Ngamazwe Ye-Heparin | |
Insimbi enzima | ≤ 30ppm | ≤ 30ppm | |
Isodium | 10.5-13.5% (into eyomile) | ———— | |
Amaprotheni | ≤ 0.5% (into eyomile) | ≤ 0.1% (isilinganiso sesisindo) | |
Umsebenzi | ≥ 180 IU/mg (into eyomile) | ≥ 180 USP U/mg (into eyomile) | |
Ukungcola Kwe-Microbial | I-TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Kuyavumelana | Kuyavumelana | |
I-Staphylococcus aureus | Kuyavumelana | Kuyavumelana | |
I-Salmonella | Kuyavumelana | Kuyavumelana |
Siyaziqhenya ngenjabulo enkulu yomthengi nokwamukelwa okubanzi ngenxa yokuphishekela kwethu ukuphishekela phezulu kwebanga ngalinye ngesixazululo nokulungiswa kwekhwalithi ephezulu yaseChina Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, abakhiqizi abakhulu be-100% eChina.Izinkampani eziningi ezihwebayo zingenisa izimpahla ezivela kithi, ngakho-ke sizokunikeza ithegi yamanani esebenza kahle kakhulu enayo yonke ikhwalithi efanayo uma unentshisekelo kithi.
Ikhwalithi ephezuluI-Enoxaparin yaseChina, I-Enoxaparin Sodium, Ukulawulwa kwekhwalithi okuqinile kwenziwa ekuxhumaneni ngakunye kwayo yonke inqubo yokukhiqiza.Sithemba ngobuqotho ukusungula ukubambisana okunobungane nokuzuzisana nawe.Ngokusekelwe ekuthengisweni kwekhwalithi ephezulu kanye nesevisi ephelele yangaphambi kokuthengisa / ngemva kokuthengisa ingumbono wethu, amanye amaklayenti abesebenzisane nathi iminyaka engaphezu kwemi-5.