Study on Micronization Technology of Alitretinoin Crude Drug / 中国药房
China Pharmacy
;
(12): 914-917, 2018.
Artigo
em Chinês
| WPRIM
| ID: wpr-704703
ABSTRACT
OBJECTIVE:
To screen the optimal micronization technology of Alitretinoin crude drug.METHODS:
Using characteristic value of particle size distribution [d(0.9)] and the content of impurity A of crude drug after crushed as indexes, crushing method(universal pulverizer,ball crusher,airslide disintegrating mill),crushing gas source(compressed air,high pressure nitrogen)and crushing pressure(0.2,0.4,0.6 MPa)of Alitretinoin crude drug were screened,and validation test was also conducted.RESULTS:
The optimal technology was as follows as airslide disintegrating mill,high pressure nitrogen as gas source,at 0.4 MPa.In validation test,particle sizes for 3 batches of crude drug after crushed were 8.57,8.55,8.54 μm(<10 μm, RSD=0.15%,n=3). The content of impurity A was not increased compared with before crushed(0.07%).CONCLUSIONS:
Screened micronization technology of Alitretinoin crude drug is feasible and stable in quality.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
China Pharmacy
Ano de publicação:
2018
Tipo de documento:
Artigo
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