摘要
通过研究粉针制剂的气流分装过程,探讨如何建立固体粉末的粉体学性质和粉针制剂产品分装质量的定量关系,以确定影响气流分装的关键因素,并通过质量源于设计的理念解决实际生产中的问题。
The behavior of powder for injection during the vacuum filling process had been systematically investigated in this paper,and key powder properties which influenced the filling weight variation were identified.This study revealed how real processing challenges in pharmaceutical industry could be successfully resolved by using the quality by design （QbD） concept,based on acquired correlation between powder properties and real performance in the production.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2014年第11期1086-1089,共4页
Chinese Journal of Pharmaceuticals
关键词
质量源于设计
气流分装
流动性
粉针制剂
quality by design
vacuum filling
flowability
powder for injection
