中国药房2018，Vol.29Issue(7)：914-917,4.DOI:10.6039/j.issn.1001-0408.2018.07.12
阿利维A酸原料药的微粉化工艺研究
Study on Micronization Technology of Alitretinoin Crude Drug
摘要
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.关键词
阿利维A酸/微粉化工艺/粉碎工艺/d(0.9)/杂质AKey words
Alitretinoin/Micronization technology/Crushing technology/d(0.9)/Impurity A分类
医药卫生引用本文复制引用
杨玉金,唐舒棠,王绍辉..阿利维A酸原料药的微粉化工艺研究[J].中国药房,2018,29(7):914-917,4.基金项目
重庆市科技计划项目(No.cstc2014kjrc-qnrc10002) （No.cstc2014kjrc-qnrc10002）
