基于工艺与装备视角分析中药制剂质量的关键影响因素
Critical influencing factors on quality of traditional Chinese medicine preparations from perspective of process and equipment
万鑫浩 1舒清霞 2王子千 3杨东印 1杨明 1王学成 1伍振峰1
作者信息
- 1. 江西中医药大学 现代中药制剂教育部重点实验室, 江西 南昌 330004
- 2. 江西省药品检验检测研究院, 江西 南昌 330004
- 3. 江西中医药大学 现代中药制剂教育部重点实验室, 江西 南昌 330004;江西省药品检查员中心, 江西 南昌 330004
- 折叠
摘要
中药制剂的质量直接关乎患者的安全,在其诸多的影响因素中以制剂的工艺环节及相应关键设备较为突出,是中药制剂质量的关键影响因素.为了更好地提高中药制剂质量,该文围绕中药制剂制造过程中各工艺环节及相应关键设备存在的问题进行总结分析,并建立以安全性和有效性为前提,结合药物自身性质、制备工艺、制剂特征的药品关键质量属性评价体系,为以质量提升为目标的工艺与设备改进提供依据.
Abstract
The quality of traditional Chinese medicine preparations is directly related to the safety of patients.Among the various factors,the process and corresponding critical equipment are critical factors influencing the quality of the preparations.To improve the quality of traditional Chinese medicine preparations,this article summarizes and analyzes the problems in the process links and corre-sponding critical equipment in the manufacturing process of traditional Chinese medicine preparations.Furthermore,a critical quality attribute evaluation system is established based on safety and effectiveness combined with the drug properties,preparation process,and preparation characteristics,providing a basis for the process and equipment improvements aimed at quality enhancement.
关键词
药品质量/中药制剂/工艺环节/关键装备/关键质量属性Key words
drug quality/traditional Chinese medicine preparations/process links/critical equipment/critical quality attribute引用本文复制引用
基金项目
国家重点研发计划项目(2023YFC3504500)
中央引导地方科技发展项目(2022ZDD03085)
江西省科技创新平台项目(20222BCD43008)
出版年
2024
NETL
NSTL
万方数据