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 ahụ ike porcine cartilage anụ ahụ.
4. Ngosipụta na ojiji: A pụrụ iji ngwaahịa a mee ihe maka nhụjuanya neuropathic, isi ọwụwa migraine, nkwonkwo mgbu, ọgwụgwọ adjuvant nke cholesterol ọbara dị elu, a pụkwara iji ya mee ihe maka mgbochi na ọgwụgwọ ọrịa atherosclerotic nke akwara ọbara, 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 a kapịrị ọnụ | -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 | ———— |