Iimveliso
I-Chondroitin Sulfate Sodium ye-Deebio yoNyango lwe-Neuropathic Pain
Iinkcukacha
1. Abalinganiswa: Umgubo omhlophe okanye phantse omhlophe, i-hygroscopic.
2. Ukukhutshwa Umthombo: Inyama yenyama yehagu efana nethambo lomqala, ithambo lempumlo, uqhoqhoqho.
3. inkqubo: I-Chondroitin Sulfate Sodium ikhutshwe kwi-porcine cartilage tissues ephilileyo.
4. Izibonakaliso kunye nokusetyenziswa: Le mveliso ingasetyenziselwa intlungu ye-neuropathic, i-migraine intloko, intlungu edibeneyo, unyango lwe-adjuvant ye-cholesterol ephezulu yegazi, ingasetyenziselwa ukuthintela kunye nonyango lwe-coronary atherosclerotic disease, ukunyuka kwegazi kunye ne-cholesterol, i-angina, i-neuralgia, ischemia ye-myocardial, i-atherosclerosis, kodwa ingasetyenziswa njengezongezelelo kukutya kunye nokutya okunempilo.
Kutheni sisi?
Upase iGMP yaseTshayina
· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D
·Imathiriyeli ekrwada iyalandeleka
·Thobela i-CP,EP,USP kunye nomgangatho womthengi
·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla
·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.
Inkcazo
| Izinto zovavanyo | Inkcazo yeNkampani | |||
| CP | EP | USP | ||
| Abalinganiswa | Imhlophe okanye iphantse ibe ngumgubo omhlophe, i-hygroscopic | Imhlophe okanye iphantse ibe ngumgubo omhlophe, i-hygroscopic | ||
| Ukuchongwa | Igrafu yeIR: Iyahambelana | Igrafu yeIR: Iyahambelana | Igrafu yeIR: Iyahambelana | |
| ISodium: Iyahambelana | ISodium: Iyahambelana | ISodium: Iyahambelana | ||
| ———— | Electrophoresis: Iyahambelana | Ukuqulunqwa kwe-disaccharide: Iyahambelana | ||
| Iimvavanyo | Ukucaca | ———— | ———— | Ngokucacileyo: A420≤ 0.35 (5%) |
| Ukujikeleziswa okuthe ngqo | -25 ° ~ -32 ° | -20.～ -30.(5%） | -20.～ -30.(30mg/ml） | |
| I-viscosity yangaphakathi | ———— | 0.01～0.15m3/kg | ———— | |
| Izinto ezinxulumeneyo | ———— | Iyahambelana | Iyahambelana | |
| pH | 6.0～7.0 | 5.5～7.5(5%） | 5.5～7.5(1%） | |
| Ilahleko ekomisweni | ≤ 10.0%(105℃ 4h） | ≤ 12.0%(105℃ 4h） | ≤ 12.0%(105℃ 4h） | |
| Intsalela ekutshisweni | 20.0%～30.0%(into eyomileyo） | ———— | 20.0%～30.0%(into eyomileyo） | |
| I-Chloride | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
| Sulfate | ≤ 0.24% | ———— | ≤ 0.24% | |
| Intsimbi enzima | ≤ 20ppm | ≤ 20ppm | ≤ 20ppm | |
| Ukucoceka kwe-Electrophoreic | ———— |
| Iyahambelana | |
| Iprotheni | ———— | ≤ 3.0%(into eyomileyo） | ≤ 6.0%(into eyomileyo） | |
| Isinyibilikisi esishiyekileyo | Iyahambelana | Iyahambelana | Iyahambelana | |
| Ii-disaccharides ezingachazwanga | ———— |
| ≤ 10.0% | |
| Umxholo | 90.0～105.0%(into eyomileyo） | 95.0～105.0% (into eyomileyo) | 90.0～105.0%(into eyomileyo） | |
| Ukungcola kweMicrobial | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g | ≤ 1000cfu/g |
| I-TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Iyahambelana | Iyahambelana | Iyahambelana | |
| Salmonella | Iyahambelana | Iyahambelana | Iyahambelana | |
| Staphylococcus aureus | ———— | Iyahambelana | ———— | |
| Pseudomonas aeruginosa | ———— | Iyahambelana | ———— | |
| I-Bile-Ukunyamezela i-Gram-Negative Bakteria | ———— | ≤ 100cfu/g | ———— | |
