一例由重金属检查发现改变生产工艺的事例  

A Case of Alteration of Production Process Prompted by Heavy Metal Inspection

作　　者：谭菊英 

机构地区：[1]广西食品药品检验所,南宁530021

出　　处：《中国药事》2016年第4期394-396,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:对一批在重金属检查中出现异常实验结果的氯化钠注射液查找原因。方法:使用HPLC法,将怀疑含有EDTA的供试液与氯化铁溶液于70℃水浴中反应20 min后测定。结果与结论:供试液中检出EDTA,解析了重金属检查中的异常现象;经药监部门现场检查,厂家使用EDTA冲洗管道后未做验证即生产样品,导致了EDTA在样品中的残留;实验室检查结果与药监部门现场检查结果一致。Objective： To find out reasons why a batch of sodium chloride injection presented an abnormal results in the experiment of heavy metal inspection. Methods： Using HPLC method, the test solution possibly containing EDTA was reacted with ferric chloride solution by heating at 70℃ in water bath for about 20 min. Results and Conclusion： EDTA was detected in the test solution, explaining the abnormal phenomenon during heavy metal inspection. According to site inspection by the drug administration department, the manufacturers produced the samples immediately after using EDTA washing line without making any authentication, resulting in residual EDTA in the samples. The laboratory results were consistent with the results of on-site inspection of the drug administration department.

关 键 词：重金属检查 生产工艺 高效液相色谱法 乙二胺四乙酸 

分 类 号：R95[医药卫生—药学] R927