摘要
文章以硬胶囊剂为例,对其微生物污染的主要来源展开分析并提出控制策略,以期提高制剂质量的安全性。为了控制中药制剂的微生物污染,需要从生产物料、人员、生产环节和运输储存等方面入手,建立起包括源头控制、增强人员能力、优化工艺流程、运输储藏管理和微生物污染风险评估等在内的系统体系。
Taking hard capsules as an example,this paper analyzes the main sources of microbial contamination and puts forward control strategies in order to improve the safety of preparation quality.To control the microbial contamination of traditional Chinese medicine preparations,it is necessary to start from the aspects of production materials,personnel,production process,transportation and storage.A systematic approach should be formed,including the source control of production materials,the improvement of the prevention and control ability of pharmaceutical employees,the optimization of the production process of traditional Chinese medicine preparations,the management of transportation and storage,and the risk assessment of microbial contamination.
作者
张诗璇
张涛
吴杰
梁晓
ZHANG Shixuan;ZHANG Tao;WU Jie;LIANG Xiao(Baoji Hospital of Traditional Chinese Medicine,Baoji 721000,Shanxi)
出处
《工业微生物》
CAS
2024年第4期138-140,共3页
Industrial Microbiology
关键词
中药制剂
硬胶囊剂
微生物污染
药品安全
traditional Chinese medicine preparations
hard capsule
microbial contamination
safety of medicines
