1. Ihe odide: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, hygroscopic.
2. Isi mmalite nke mmịpụta: anụ ahụ cartilage porcine dị ka ọkpụkpụ akpịrị, ọkpụkpụ imi, trachea.
3. usoro: Chondroitin Sulfate Sodium na-amịpụtara si ike porcine cartilage anụ ahụ.
4. Ngosipụta na ojiji: Enwere ike iji ngwaahịa a maka mgbu neuropathic, isi ọwụwa migraine, nkwonkwo nkwonkwo, ọgwụgwọ adjuvant nke cholesterol ọbara dị elu, a pụkwara iji ya mee ihe maka igbochi na ọgwụgwọ ọrịa atherosclerotic na-arịa ọrịa obi, ọbara na cholesterol ịrị elu, angina, neuralgia, myocardial ischemia, atherosclerosis, mana enwere ike iji ya dị ka mgbakwunye na nri na nri ahụike.
· Gafere GMP nke China
· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D
· A na-achọpụta ihe ọkụkụ
Soro CP, EP, USP na ọkọlọtọ ndị ahịa
· Mbupụ gaa na mba na mpaghara iri atọ
· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.
Nnwale ihe | Nkọwapụta ụlọ ọrụ | |||
CP | EP | USP | ||
Ndị agwa | White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, hygroscopic | White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ, hygroscopic | ||
njirimara | Eserese IR: Dabara | Eserese IR: Dabara | Eserese IR: Dabara | |
Sodium: dabara | Sodium: dabara | Sodium: dabara | ||
———— | Electrophoresis: kwekọrọ | Ngwakọta Disaccharide: kwekọrọ | ||
Nnwale | Ido anya | ———— | ———— | doro anya: A4200.35 (5%) |
Ntụgharị akọwapụtara | -25° ~ -32° | -20.~ -30.(5%) | -20.~ -30.(30 mg / ml) | |
Viscosity dị n'ime | ———— | 0.01~0.15m3 / n'arọ | ———— | |
Ihe ndị metụtara ya | ———— | Dabara | Dabara | |
pH | 6.0~7.0 | 5.5~7.5(5%) | 5.5~7.5(1%) | |
Ọnwụ na ihicha | ≤10.0%(105 ℃ 4h) | ≤12.0%(105 ℃ 4h) | ≤12.0%(105 ℃ 4h) | |
Ihe fọdụrụ na mgbanye | 20.0%~30.0%(akọrọ ihe) | ———— | 20.0%~30.0%(akọrọ ihe) | |
Chloride | ≤0.5% | ≤0.5% | ≤0.5% | |
Sulfate | ≤0.24% | ———— | ≤0.24% | |
Igwe dị arọ | ≤20pm | ≤20pm | ≤20pm | |
Electrophoreic ịdị ọcha | ———— |
| Dabara | |
Protein | ———— | ≤ 3.0%(akọrọ ihe) | ≤ 6.0%(akọrọ ihe) | |
Ihe mgbaze fọdụrụnụ | Dabara | Dabara | Dabara | |
Disaccharides enweghị nkọwa | ———— |
| ≤10.0% | |
Ọdịnaya | 90.0~105.0%(akọrọ ihe) | 95.0~105.0% (ihe kpọrọ nkụ) | 90.0~105.0%(akọrọ ihe) | |
Microbial adịghị ọcha | TAMC | ≤1000cfu/g | ≤1000cfu/g | ≤1000cfu/g |
TYMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | |
E.coli | Dabara | Dabara | Dabara | |
Salmonella | Dabara | Dabara | Dabara | |
Staphylococcus aureus | ———— | Dabara | ———— | |
Pseudomonas aeruginosa | ———— | Dabara | ———— | |
Bacteria gram-adịghị mma nke Bile-Tolerant | ———— | ≤100cfu/g | ———— |