安瓿小容量注射剂可见异物的来源及控制措施

Source and Solving Methods of Visible Foreign Matters in Small Volume Injection Ampoule

可见异物是安瓿小容量注射剂生产过程中极难控制但又必须重点关注的问题。若注射剂中不慎混入可见异物,便会经由静脉注射直接进入人体,造成血管炎、血栓、微血管阻塞等病症,极大地危害人体健康。本研究拟分析安瓿小容量注射剂可见异物的来源,提出安瓿小容量注射剂可见异物的控制措施,以提高安瓿小容量注射剂的生产质量,杜绝用药安全事故。

Visible foreign substances is extremely difficult to control in the production process of small volume injection, but we must pay attention to the problem. Because the visible foreign substances accidentally mixed into the injection,it will directly enter into the body via intravenous injection,caused by vasculitis,thrombosis and micro vascular occlusion disorder,greatly endangering the health of human body.In view of this,the paper analyses the source of visible foreign substances in the small volume injections,puts forward the control measures of visible foreign substances in the ampoule small volume injection,in order to improve the production quality of the ampoule small volume injection,eliminate the safety accident.