亮菌甲素注射液应急检验排查实践研究(一)

Practice Research on Emergency Testing Investigation of the Armillarisin A Injection(Ⅰ)

目的全面、真实地记载了广东省药品检验所在2006年应急检验排查齐齐哈尔第二制药有限公司生产的亮菌甲素注射液的质量过程。方法历时12天,开展了标准检验排查、比对检验排查、对比实验排查、辅料信息排查、辅料毒性排查、外调生产工艺、辅料杂质排查、检查二甘醇、建立补充方法、出具鉴定报告、建立快筛方法、全面总结研究等12个步骤。形成了职责导向、循症溯源、循证系统三条思维路径。结果与结论完成了亮菌甲素注射液应急检验排查的艰巨任务。

Objective Guangdong Institute for Drug Control participated in the treatment on the counterfeit incident of Qiqihaer second pharmaceutical factory in 2006. In this paper, the process of the emergency testing investigation on the drug quality of the Armillarisin A injection was recorded completely and factually. Methods It took 12 days and 12 steps to accomplish the investigation, such as to carry on the standard tests investigation, the comparative test investigation, the comparative experiment investigation, the complement information investigation, the complement toxic investigation, the production process investigation, the complement impurities investigation, checking diethylene glycol, the establishment of additional methods, issuing the identification report, the establishment of rapid screening methods and a comprehensive study, which formed three paths of thinking such as a duty-oriented, traceable through disease and evidence-based system. Results and Conclusions To complete the task of emergency testing of Armillarisin A Injection.