Hua
Ko te Chondroitin Sulfate Sodium o Deebio mo te rongoa i te mamae Neuropathic
Taipitopito
1. Ngā Pūāhua: Te paura mā, tata mā rānei, he hygroscopic.
2. Te Puna Tangohanga: Ko nga kopa kirikiri porcine penei i te koiwi korokoro, ihu ihu, trachea.
3. tukanga: Ko te Chondroitin Sulfate Sodium ka tangohia mai i nga kopa kirikiri porcine hauora.
4. Nga tohu me nga whakamahinga: Ka taea te whakamahi i tenei hua mo te mamae neuropathic, te mamae o te migraine, te mamae tahi, te maimoatanga awhina o te cholesterol toto tiketike, ka taea hoki te whakamahi mo te aukati me te maimoatanga o te mate atherosclerotic coronary, te toto me te cholesterol piki, angina, neuralgia, ischemia myocardial, atherosclerosis, engari ka taea hoki te whakamahi hei taapiri mo te kai me te kai hauora.
He aha tatou?
· I paahitia te GMP Hainamana
· 27 nga tau o te hitori R&D o te enzyme koiora
· Ka taea te rapu i nga rawa mata
· Whakaritea ki te CP, EP, USP me te paerewa kiritaki
· Kaweake ki runga i te 30 whenua me nga rohe
· He kaha ki te whakahaere punaha kounga penei i te US FDA, Japan PMDA, South Korea MFDS, etc.
Whakatakotoranga
| Nga Tuemi Whakamatau | Whakatakotoranga Kamupene | |||
| CP | EP | USP | ||
| Pūāhua | Te paura ma, tata ma ranei, he hygroscopic | Te paura ma, tata ma ranei, he hygroscopic | ||
| Tautuhinga | Kauwhata IR: He rite | Kauwhata IR: He rite | Kauwhata IR: He rite | |
| Konutai: Ka rite | Konutai: Ka rite | Konutai: Ka rite | ||
| ———— | Electrophoresis: Ka rite | Te hanganga o te Disaccharide: He rite | ||
| Nga whakamatautau | Maramarama | ———— | ———— | Maamaa: A420≤ 0.35 (5%) |
| Hurihuri motuhake | -25°~ -32° | -20.～ -30.（5%） | -20.～ -30.（30mg/ml） | |
| Te pokeytanga o roto | ———— | 0.01～0.15m3/kg | ———— | |
| Matū whai pānga | ———— | Ka rite | Ka rite | |
| pH | 6.0～7.0 | 5.5～7.5（5%） | 5.5～7.5（1%） | |
| Ngaronga i te whakamaroke | ≤ 10.0%（105℃ 4h） | ≤ 12.0%（105℃ 4h） | ≤ 12.0%（105℃ 4h） | |
| Te toenga i runga i te mura | 20.0%～30.0%（matū maroke） | ———— | 20.0%～30.0%（matū maroke） | |
| pūhaumāota | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
| pūwhawhā | ≤ 0.24% | ———— | ≤ 0.24% | |
| Te whakarewa taumaha | ≤ 20ppm | ≤ 20ppm | ≤ 20ppm | |
| Pure Hiko | ———— |
| Ka rite | |
| Pūmua | ———— | ≤ 3.0%（matū maroke） | ≤ 6.0%（matū maroke） | |
| Te toenga whakarewa | Ka rite | Ka rite | Ka rite | |
| Nga haupapa kore motuhake | ———— |
| ≤ 10.0% | |
| Ihirangi | 90.0～105.0%（matū maroke） | 95.0～105.0% (matū maroke) | 90.0～105.0%（matū maroke） | |
| Nga poke moroiti | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g | ≤ 1000cfu/g |
| TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ka rite | Ka rite | Ka rite | |
| Haramona | Ka rite | Ka rite | Ka rite | |
| Staphylococcus aureus | ———— | Ka rite | ———— | |
| Pseudomonas aeruginosa | ———— | Ka rite | ———— | |
| Huakita Gram-Negative Bile-Tolerant | ———— | ≤ 100cfu/g | ———— | |
