Isu tinoedza kuita zvakanaka, kambani nevatengi ”, inotarisira kuve timu yakanakisa yekubatana uye inotonga bhizinesi revashandi, vatengesi nevatengi, vanoona kukosha kwekugovana uye kuenderera mberi kushambadza kweKushanda Kwepamusoro.China Heparin Sodium, Isu hatingounze iwo emhando yepamusoro kune vatengi vedu, asi zvakatokosha zvakanyanya masevhisi edu makuru pamwe nemakwikwi ekutengesa mutengo.
Isu tinoedza kuita zvakanaka, kambani nevatengi ”, inotarisira kuve timu yakanakisa yekushandira pamwe uye bhizinesi rekutonga kune vashandi, vatengesi nevatengi, vanoona kukosha kwekugovana uye kuenderera mberi kwekushambadziraChina Heparin Sodium, Kugutsikana kweMutengi kunogara kuchishuva kwedu, kugadzira kukosha kwevatengi ibasa redu nguva dzose, hukama hwebhizinesi hunobatsira kwenguva refu ndizvo zvatiri kuitira.Isu tanga tiri shamwari yakavimbika yakavimbika munyaya yako kuChina.Ehe, mamwe masevhisi, sekubvunzana, anogona kupihwa zvakare.
1. Mavara: Ichena kana inenge chena poda, yakanyanya hygroscopic.
2. Kunobva: Porcine intestine mucosa.
3. Nzira: Heparin sodium inotorwa kubva kune utano hweporcine intestine mucosa.
4. Zviratidzo uye kushandiswa: Ichi chigadzirwa chinonyanya kushandiswa kudzivirira chirwere che thromboembolic, kunyanya kukodzera kudiwa kwe anticoagulant nokukurumidza, zvakadai se: 1. Acute kana kusingaperi venous thrombosis kana kusakosha kweropa kuyerera kwekuchinja kwe pulmonary embolism (PE) .Heparin inogona kumisa embolus yekuwedzera kuita nguva yekuzviitira thrombolysis yemuviri.2. Kudzivirira uye kurapwa kweAtrial fibrillation ne embolism.3. Kurapa kwekutanga diffuse intravascular coagulation (DIC).4. Kudzivirira uye kurapwa kweperipheral arterial thrombosis kana myocardial infarction.5. Zvimwe in vitro anticoagulation: zvakadai sekuvhiyiwa kwemwoyo, in vitro circulation, hemodialysis, angiography, inogonawo kushandiswa kuwedzerwa ropa kana kugadzirira kwemuenzaniso weropa, parizvino zviratidzo zvikuru zvekushandiswa kweheparin ndeye deep vein thrombosis (DVT), PE uye thrombosis. muvarwere vane njodzi huru.
· Vakapfuura Chinese GMP
· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo
·Maraw materials anotarisika
·Teerera neUSP,EP uye mwero wevatengi
·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu
·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.
Test Items | Kutsanangurwa kwekambani | ||
EP | USP | ||
Vanhu | Ichena kana inenge chena poda, yakanyanya hygroscopic | ||
Identification | Thrombotest: Inopindirana | Chromatographic identity: Inopindirana | |
1H NMR Spectrum: Inopindirana | 1H NMR Spectrum: Inopindirana | ||
Liquid Chromatography: Inopindirana | Huremu-avhareji yemamorekuru uremu: 15000 ~ 19000 | ||
Sodium: Inopindirana | Sodium: Inopindirana | ||
Anti-factor Xa kune anti-factor IIa chiyero:0.9 ~ 1.1 | Anti-factor Xa kune anti-factor IIa chiyero:0.9 ~ 1.1 | ||
Miedzo | Kujeka uye ruvara | Kujeka: Zvakajeka, Ruvara: ne5 kana kupfuura | ———— |
Nitrogen | 1.5 - 2.5% (chinhu chakaoma) | 1.3 - 2.5% (chinhu chakaoma) | |
Nucleotidic tsvina | A260≤ 0.15(4mg/ml) | ≤ 0.1 (w/w) | |
Zvinhu zvinoenderana | Conforms | ———— | |
Muganho wegalactosamine mune yakazara hexosamine | ———— | ≤ 1.0% | |
Oversulfated chondroitin sulfate | ———— | Conforms | |
pH | 5.5 -8.0 (1%) | 5.5 -7.5 (1%) | |
Kurasikirwa pakuomeswa | ≤ 8.0% (60 ℃ Dry in Vacuum, 3h) | ≤ 5.0% (60 ℃ Dry in Vacuum, 3h) | |
Residue pakubatidza | ———— | 28.0%~41.0% | |
Bacterial endotoxin | ≤ 0.01 IU/International Unit yeHeparin | ≤ 0.03 USP U/International Unit yeHeparin | |
Simbi inorema | ≤ 30ppm | ≤ 30ppm | |
Sodium | 10.5 - 13.5% (chinhu chakaoma) | ———— | |
Mapuroteni | ≤ 0.5% (chinhu chakaoma) | ≤ 0.1% (uremu reshiyo) | |
Chiitiko | ≥ 180 IU/mg (chinhu chakaoma) | ≥ 180 USP U/mg (chinhu chakaoma) | |
Kusvibiswa kweMicrobial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Conforms | Conforms | |
Staphylococcus aureus | Conforms | Conforms | |
Salmonella | Conforms | Conforms |
Isu tinoedza kuita zvakanaka, kambani nevatengi ”, inotarisira kuve timu yakanakisa yekubatana uye inotonga bhizinesi revashandi, vatengesi nevatengi, vanoona kukosha kwekugovana uye kuenderera mberi kushambadza kweKushanda Kwepamusoro.China Heparin SodiumIsu hatingounze iwo emhando yepamusoro kune vatengi vedu, asi zvakatonyanya kukosha masevhisi edu makuru pamwe nemakwikwi ekutengesa mutengo.
High Performance China Heparin, kugutsikana kweMutengi kunogara kuchishuva kwedu, kugadzira kukosha kwevatengi ibasa redu nguva dzose, hukama hwebhizinesi hunobatsira kwenguva refu ndizvo zvatiri kuitira.Isu tanga tiri shamwari yakavimbika yakavimbika munyaya yako kuChina.Ehe, mamwe masevhisi, sekubvunzana, anogona kupihwa zvakare.