相对密闭环境配药新模式对药品中不溶性微粒的影响

Effect of relatively closed environment dispensing new mode on insoluble particles in pharmaceuticals

摘要:

目的 研究相对密闭环境药品配置模式对药品中不溶性微粒的影响。方法 检测Ⅰ类环境和Ⅲ类环境中常规配药模式与相对密闭环境配药模式的不溶性微粒数量，比较不同配药模式对药品中不溶性微粒数量的影响。结果 手工配药时Ⅰ类环境中1~10 μm各组别不溶性微粒数少于Ⅲ类环境，差异均有统计学意义（均P<0.05）。采用相对密闭环境配药新模式时Ⅰ类环境中1~15 μm各组别不溶性微粒数与Ⅲ类环境比较，差异均无统计学意义（均P>0.05）。在Ⅲ类环境中采用相对密闭环境配药新模式时1~20 μm各组别不溶性微粒数少于手工配药，差异均有统计学意义（均P<0.05）。在Ⅰ类环境中采用相对密闭环境配药新模式时1~15 μm各组别不溶性微粒数少于手工配药，差异均有统计学意义（均P<0.05）。在I类环境中进行手工配药时1~15 μm各组别不溶性微粒数均多于在Ⅲ类环境中进行相对密闭环境配药，差异均有统计学意义（均P<0.05）。结论 相对密闭环境配药模式能有效降低药品配置过程中环境微粒进入静脉输液系统中。

Abstract:

Objective To study the effect of relatively closed environment dispensing mode on insoluble particles in pharmaceuticals. Methods The numbers of insoluble particles in conventional manual dispensing mode and relatively closed environment dispensing mode in lass Ⅰ and class Ⅲ environment were detected, effect of different dispensing modes on the number of insoluble particles in pharmaceuticals was compared. Results When adopting manual dispensing, the numbers of 1-10 μm insoluble particulates in different groups in class Ⅰ environment were less than those in class Ⅲ environment respectively, differences were all statistically significant (all P<0.05). When adopting a new mode of dispensing in relatively closed environment, there was no significant difference in the numbers of 1-15 μm insoluble particulates in different groups between class Ⅰ and class Ⅲ environment respectively (all P>0.05). The numbers of 1-20 μm and 1-15 μm insoluble particles in different groups were less than those in manual dispensing when the new mode of dispensing were adopted in class Ⅲ and class Ⅰenvironment respectively, differences were all statistically significant (all P<0.05). The numbers of 1-15 μm insoluble particles in different groups in manual dispensing in class Ⅰ environment were more than those in class Ⅲ environment respectively, difference were all statistically significant (all P<0.05). Conclusion The relatively closed environment dispensing mode can effectively reduce environmental particulates entering intravenous infusion system during dispensing process.