1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, i-hygroscopic.
2. Umthombo Wokukhipha: Izicubu ze-porcine cartilage njengethambo lomphimbo, ithambo lekhala, uqhoqhoqho.
3. inqubo: I-Chondroitin Sulfate Sodium ikhishwa ezicutshini ze-porcine cartilage enempilo.
4. Izinkomba kanye nokusetshenziswa: Lo mkhiqizo ungasetshenziselwa ubuhlungu be-neuropathic, ubuhlungu bekhanda le-migraine, ubuhlungu obuhlangene, ukwelashwa kwe-adjuvant ye-cholesterol ephezulu yegazi, ungasetshenziswa futhi ukuvimbela nokwelashwa kwesifo se-coronary atherosclerotic, ukukhuphuka kwegazi ne-cholesterol, i-angina, i-neuralgia, I-myocardial ischemia, isifo sokuqina kwemithambo yegazi, kodwa futhi ingasetshenziswa njengesengezo ekudleni nasekudleni kwezempilo.
·Uphumelele i-Chinese GMP
·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D
·Izinto ezingavuthiwe ziyalandeleka
·Thobela i-CP,EP,USP 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 | |||
CP | EP | USP | ||
Izinhlamvu | Impushana emhlophe noma ecishe ibe mhlophe, i-hygroscopic | Impushana emhlophe noma ecishe ibe mhlophe, i-hygroscopic | ||
Ukuhlonza | Igrafu ye-IR: Iyavumelana | Igrafu ye-IR: Iyavumelana | Igrafu ye-IR: Iyavumelana | |
I-Sodium: Iyavumelana | I-Sodium: Iyavumelana | I-Sodium: Iyavumelana | ||
———— | I-Electrophoresis: Iyavumelana | Ukwakheka kwe-Disaccharide: Kuyavumelana | ||
Izivivinyo | Ukucaca | ———— | ———— | Kucacile: A420≤ 0.35 (5%) |
Ukuzungezisa okuqondile | -25°~ -32° | -20.~ -30.(5%) | -20.~ -30.(30mg/ml) | |
I-viscosity yangaphakathi | ———— | 0.01~0.15m3/kg | ———— | |
Izinto ezihlobene | ———— | Kuyavumelana | Kuyavumelana | |
pH | 6.0~7.0 | 5.5~7.5(5%) | 5.5~7.5(1%) | |
Ukulahlekelwa ekomisweni | ≤ 10.0%(105℃ 4h) | ≤ 12.0%(105℃ 4h) | ≤ 12.0%(105℃ 4h) | |
Izinsalela ekushiseni | 20.0%~30.0%(into eyomile) | ———— | 20.0%~30.0%(into eyomile) | |
I-Chloride | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
I-sulfate | ≤ 0.24% | ———— | ≤ 0.24% | |
Insimbi enzima | ≤ 20ppm | ≤ 20ppm | ≤ 20ppm | |
Electrophoreic Purity | ———— |
| Kuyavumelana | |
Amaprotheni | ———— | ≤ 3.0%(into eyomile) | ≤ 6.0%(into eyomile) | |
I-solvent eyinsalela | Kuyavumelana | Kuyavumelana | Kuyavumelana | |
Ama-disaccharides angaqondile | ———— |
| ≤ 10.0% | |
Okuqukethwe | 90.0~105.0%(into eyomile) | 95.0~105.0% (into eyomile) | 90.0~105.0%(into eyomile) | |
Ukungcola Kwe-Microbial | I-TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g | ≤ 1000cfu/g |
I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Kuyavumelana | Kuyavumelana | Kuyavumelana | |
I-Salmonella | Kuyavumelana | Kuyavumelana | Kuyavumelana | |
I-Staphylococcus aureus | ———— | Kuyavumelana | ———— | |
I-Pseudomonas aeruginosa | ———— | Kuyavumelana | ———— | |
I-Bile-Tolerant Gram-Negative Bacteria | ———— | ≤ 100cfu/g | ———— |