摘要
文章主要是对于可见异物检查中注射用无菌制剂和无菌原料药样品制备方法的考察。在实验过程中,主要采用光散射可见异物检测仪考察水的处理、注射器与西林瓶的清洗与无菌原料药的称量方法。最后,能够得到以下结论:注射用无菌制剂和无菌原料药样品制备过程中的多个环节均有引入外来异物的风险,需要建立科学可行的样品制备与验证方法。
This article is mainly about the investigation of the preparation methods of sterile preparations for injection and sterile API samples in the examination of visible foreign bodies. During the experiment, the light scattering visible foreign body detector was mainly used to investigate the water treatment, the cleaning of syringes and vials, and the weighing method of sterile APIs. Finally, the following conclusions can be drawn: there is a risk of introducing foreign substances in many links of the preparation of sterile preparations for injection and sterile API samples, and a scientific and feasible sample preparation and validation method needs to be established.
作者
李帅
刘雁鸣
李昭
王皖
唐桂鹏
廖彬
LI Shuai;LIU Yan Ming;LI Zhao;WANG Wan;LIAO Bin(Hunan Institute for Drug Control,Changsha 410001,China;Hunan Engineering驭Technology Research Center for Pharmaceutical Quality Evaluation;Hunan Drug Inspection Center,Changsha 410001,China)
出处
《工业微生物》
CAS
2023年第1期70-72,共3页
Industrial Microbiology
基金
2021年湖南省科技厅科药联合基金(2021JJ80033)阶段性成果。
关键词
可见异物
光散射法
灯检法
注射用无菌制剂
注射用无菌原料药
visible particles
lamp test
light scattering method
sterile preparations for injection
sterile API for injection
