用不同方法测定微粒污染的探讨  

Determination the Particulate Matter in Injection with Different Methods

作　　者：徐超斗[1] 陶胜源[1] 魏萍[1] 陈善[1] 

机构地区：[1]中国人民解放军总后勤部卫生部药品仪器检验所,北京100071

出　　处：《解放军药学学报》2002年第5期314-315,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　研究不同方法检测注射液中不溶性微粒的准确性。方法　采用光阻法和电阻法分别测定粒径为 10 .2 μm、2 5 .8μm标准微粒和一次性使用输液器所含微粒。 结果　光阻法和电阻法测得标准溶液中微粒的微粒计数值分别为 16 10± 2 8.2 /ml、15 0 2± 10 .0 /ml(粒径 10 .2 μm ,标示值 15 10 /ml) ,12 39± 5 .8/ml、95 6± 9.5 /ml(粒径 2 5 .8μm ,标示值 96 6 /ml) ,光阻法明显高于电阻法。同样 ,一次性使用输液器中所含微粒的测定结果 ,光阻法测定的数值高于电阻法。结论　采用不同方法检测微粒 。Aim To study the accuracy of determination of particulate matter in injection with different methods.Methods Determination of particle counts of 10.2μm,25.8μm standard particulate matter and infusion sets for single use with light obscuration method and electrical zone-sensing method respectively.Results The particle counts are 1 610±28.2/ml,1 502±10.0/ml (diameters 10.2μm particle size standard,labbled value is 1 510/ml) and 1 239±5.8/ml,956±9.5/ml (diameters 25.8μm particle size standard,labbled value is 966/ml) with light obscuration method and electrical zone-sensing method respectively.The particle count in infusion sets for single use is higher with light obscuration method than that with electrical zone-sensing method.Conclusion There are some different in the determination of particle counts with different methods.

关 键 词：微粒污染 光阻法 电阻法 一次性使用输液器 注射液 

分 类 号：R927.1[医药卫生—药学]