1. Characters: Caddaan ama ku dhawaad budo cad, hygroscopic.
2. Isha Soo saarista: Unugyada carjawda Porcine sida lafta dhuunta, lafta sanka, trachea.
3. habka: Chondroitin Sulfate Sodium waxaa laga soo saaraa unugyo carjawda boorash caafimaad qaba.
4. Tilmaamaha iyo isticmaalka: Alaabtan waxaa loo isticmaali karaa xanuunka neuropathic, madax xanuunka dhanjafka, xanuunka kala goysyada, daaweynta adjuvant ee kolestaroolka dhiigga oo sarreeya, sidoo kale waxaa loo isticmaali karaa ka hortagga iyo daaweynta cudurrada halbowlaha wadnaha, dhiigga iyo kolestaroolka kor u kaca, angina, neuralgia. myocardial ischemia, atherosclerosis, laakiin sidoo kale waxaa loo isticmaali karaa sida lagu daro cuntada iyo caafimaadka-cuntada.
Wuxuu gudbay GMP-ga Shiinaha
· 27 sano oo enzyme bayooloji R&D taariikhda
Qalabka ceeriin waa la raadin karaa
U hoggaansamaan CP, EP, USP iyo 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 | |||
CP | EP | USP | ||
Jilayaasha | Budada cad ama ku dhawaad cad, hygroscopic | Budada cad ama ku dhawaad cad, hygroscopic | ||
Aqoonsiga | garaafka IR: Waafaqayaa | garaafka IR: Waafaqayaa | garaafka IR: Waafaqayaa | |
Sodium: Waafaqsan | Sodium: Waafaqsan | Sodium: Waafaqsan | ||
———— | Electrophoresis: Waa waafaqsan yahay | Halabuurka Disaccharide: Waa waafaqsan yahay | ||
Tijaabooyin | Caddayn | ———— | ———— | Cad: A420≤ 0.35 (5%) |
Wareeg gaar ah | -25°~ -32° | -20.~ -30.(5%) | -20.~ -30.(30mg/ml) | |
Viscosity gudaha | ———— | 0.01~0.15m3/kg | ———— | |
Walxaha la xidhiidha | ———— | waafaqsan | waafaqsan | |
pH | 6.0~7.0 | 5.5~7.5(5%) | 5.5~7.5(1%) | |
Luminta qalajinta | ≤ 10.0%(105 ℃ 4 saac) | ≤ 12.0%(105 ℃ 4 saac) | ≤ 12.0%(105 ℃ 4 saac) | |
Hadhaaga dabka | 20.0%~30.0%(walax qalalan) | ———— | 20.0%~30.0%(walax qalalan) | |
Chloride | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
Sulfate | ≤ 0.24% | ———— | ≤ 0.24% | |
Bir culus | ≤20pm | ≤20pm | ≤20pm | |
Nadiifnimada Electrophoreic | ———— |
| waafaqsan | |
Protein | ———— | ≤ 3.0%(walax qalalan) | ≤ 6.0%(walax qalalan) | |
dareere haraaga ah | waafaqsan | waafaqsan | waafaqsan | |
Disaccharides aan gaar ahayn | ———— |
| ≤ 10.0% | |
Nuxurka | 90.0~105.0%(walax qalalan) | 95.0~105.0% (qalalan) | 90.0~105.0%(walax qalalan) | |
wasakhda Microbial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan | waafaqsan | |
Staphylococcus aureus | ———— | waafaqsan | ———— | |
Pseudomonas aeruginosa | ———— | waafaqsan | ———— | |
Bakteeriyada Bile-Dulqaadka Gram-Negative | ———— | ≤ 100cfu/g | ———— |