光阻法对注射液不溶性微粒检测的准确性影响因素探讨

Factors affecting accuracy of light-blockage detection of insoluble particles in injections

本文通过对注射液不溶性微粒检测的常用仪器——光阻法微粒检测仪的原理分析,探讨了该类方法的局限性(介质特性、气泡及取样结构)对检测的影响;并总结了正确使用方法及注意事项。只有正确使用微粒检测仪,才能保证样品检测的准确性。

In this paper,we have investigated the limitation of the light blockage based particle dectors by analyzing its working mechanism of insoluble particle test of injection preparations. We explored the effect of solution properties,air bubbles and sampling structure on test accuracy,and summarized a correct method and cautions for dection operation. We found that a correct operation is very important for an accurate test result.