Study on Micronization Technology of Alitretinoin Crude Drug
10.6039/j.issn.1001-0408.2018.07.12
- VernacularTitle:阿利维A酸原料药的微粉化工艺研究
- Author:
Yujin YANG
1
;
Shutang TANG
;
Shaohui WANG
Author Information
1. 重庆华邦制药有限公司研发中心
- Keywords:
Alitretinoin;
Micronization technology;
Crushing technology;
d(0.9);
Impurity A
- From:
China Pharmacy
2018;29(7):914-917
- CountryChina
- Language:Chinese
-
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.
