Ngwaahịa
Ursodeoxycholic acid (UDCA) nke Deebio maka ọgwụgwọ nke nkume gallstone
Nkọwa
1. Ihe odide: White ntụ ntụ;enweghị isi.Ngwaahịa a bụ soluble na ethanol, ma ọ dịghị soluble na chloroform;soluble na glacial acetic acid, na soluble na sodium hydroxide ule ngwọta.
2. Usoro: sịntetik.
3. Ngosipụta na ojiji: Maka ọgwụgwọ nke gallstones, ọrịa imeju cholestatic, imeju abụba, ụdị ịba ọcha n'anya dị iche iche, ọrịa imeju na-egbu egbu, cholecystitis, cholecystitis na biliary dyspepsia, bile reflux gastritis, wdg.
Gịnị mere anyị?
· Emepụtara n'ụlọ ọrụ GMP
· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D
· A na-achọpụta ihe ọkụkụ
Soro ụkpụrụ ndị ahịa na ụlọ ọrụ
· Mbupụ gaa na mba na mpaghara iri atọ
· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.
Nkọwapụta
| Nnwale ihe | Dịka ọkọlọtọ ime na ọkọlọtọ ndị ahịa si dị | |
| Mpụta | Na-acha ọcha ma ọ bụ ọ fọrọ nke nta ka ọ bụrụ ntụ ntụ. | |
| OGE na-agbaze | N'etiti 200 ° C na 205 ° C | |
| NTỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKW ahụ kpọmkwem | +57.0 “+62.0° | |
| Mfu na ịsa | ≤0.5% | |
| AKWỤKWỌ NA MKWA | ≤0.1% | |
| ASSAY | 98.5% ~ 101.5% (ihe akpọnwụwo) | |
| Ọcha (HPLC) | ≥98.5% | |
| Ihe metụtara (HPLC) | ≤1.5% (Chenodeoxycholicacid) | Achọpụtaghị |
| ≤0.1% (adịghị ọcha na-akọwapụtaghị) | 0.05% | |
| ≤0.1% (Lithocholicacid) | Achọpụtaghị | |
| ≤1.5% (Ngụkọta) | 0.10% | |
| Ihe emetụtara (TLC) | ≤O.05% (Lithocholic acid) | Na-akwado |
| ≤1.5% (Chenodeoxycholicacid) | Na-akwado | |
| Ngwọta fọdụrụnụ | Acetone: ≤5000ppm | |
| Mkpokọta AEROBIC MICROBIAL COUNT | 103cfu/g | |
| Mkpokọta yist ejikọta ọnụ/MULỤ | 102cfu/g | |
| E.COLI | Na-akwado | |
| SALMONELLAE | Na-akwado | |
| NKWUBIOKWU | tozuru oke | |
