新型溶药器对减少静脉药物配置中不溶性微粒污染的作用研究  

Effects of Insoluble Particle Pollution of Intravenous Admixture Reduce by New Medicine Dissolution Apparatus

作　　者：王晓红[1] 崔秀彦[1] 李红娜[1] 王耀华[1] 赵丹宁[1] 

机构地区：[1]河北大学附属医院,河北保定071000

出　　处：《中国药房》2012年第29期2718-2720,共3页China Pharmacy

摘　　要：目的:研究影响静脉药物复配液中微粒含量的因素,探讨减少不溶性微粒的最佳方法。方法:以≥10μm和≥25μm不溶性微粒数为指标,采用光阻法对注射用氨苄西林钠在不同配液器具(一次性注射器、自制新型溶药器)、配液环境(治疗室、静脉配置中心(PIVAS))、药物剂量(3、6支)下的复配液进行微粒测定。结果:相同条件下,溶药器组比注射器组微粒数目明显更少(P<0.001);用注射器配置时,PIVAS组比治疗室组在配置相同剂量的复配液时微粒数目明显更少(P<0.001);在相同配液环境中3支组比6支组微粒数目明显更少(P<0.05或P<0.001);用溶药器配置时,PIVAS组与治疗室组、3支组与6支组比较无明显差异(P>0.05)。结论:新型溶药器能明显减少复配液中的不溶性微粒,同时不易受配液环境、药物剂量的影响。OBJECTIVE： To study the influencing factors of the content of particles in intravenous compound liquid mixture, and to discuss the optimal method of reducing insoluble particles. METHODS： Using ≥10 μtm and ≥25 μm of insoluble particle number as index, light blockage method was used to determine the particle in compound liquid mixture of Ampicillin sodium for in- jection by different apparatus （disposable syringe, self-made new medicine dissolution apparatus） in different mixing environment （therapeutic department, PIVAS） at different doses （3 or 6 bottles）. RESULTS： Under the same conditions, particle number of medicine dissolution apparatus group was significantly fewer than that of syringe group （P〈0.001） ; using a syringe, particle num- ber of PIVAS group was significantly fewer than therapeutic department group when using same dose of compound mixture （P〈 0.001） ; under same mixing environment, particle number of 3 bottles group was fewer than that of 6 bottles group （P〈0.05 or P〈 0.001）; using medicine dissolution apparatus, there was no significant difference between PIVAS group and therapeutic department group, 3 bottles group and 6 bottles group （P〉0.05）. CONCLUSION： New medicine dissolution apparatus can significantly re-duce the generation of insoluble particle in compound liquid mixture, and is not affected by fluid mixing environment and drug dos- age easily.

关 键 词：不溶性微粒 配液环境 配液容器 药物剂量 复配液 

分 类 号：R927.11[医药卫生—药学]