超声处理对光阻法测定注射液中不溶性微粒的影响

Effect of Sonicating on Determinaton of Particulate Matter in Injections by minutes Laser Injection Particule Count

目的研究超声处理对光阻法测定注射液中不溶性微粒的影响。方法按中国药典2000年版注射液中不溶性微粒检查法,将注射液经静置或经一定功率、一定时间的超声处理后,以激光注射液微粒分析仪测定注射液中的≥5μm,≥10μm,≥15μm,≥20μm,≥25μm,≥32μm微粒数量。结果同一注射液经静置处理或经超声处理后,微粒计数值不同;同一注射液经不同功率及不同时间超声处理后,微粒计数值不同。结论超声处理对光阻法测定注射液中不溶性微粒计数值有影响。

Aim To investigate the effect of Sonicating on detemainating particulate matter in injections by Laser Injection Particule count. Method To degas the particle solution by keep it standing by sonicating for 30 seconds 1 minite 2minites 3minites at 100 or 300 wattes and count ≥5μm,≥10μm,≥15μm,≥20μm,≥25μm,≥32μm particle.Result After being degased by sonicating for 30 seconds 1 minute 2minutes 3minutes at 100 or 300 wattes, particle numbers were changed. Conclusion Sonication can change particle numbers detemainated, by laser injection particule count.