目的 评价双室袋法与注射器法配制静脉输液在临床使用的安全性差异。方法 采用光阻法分别测定配制前粉体、液体和双室袋法或注射器法配制后混合液共880份样品中不溶性微粒的大小和数量,考察两种配制方法对溶液不溶性微粒的影响。结果 注射器法配制后各粒径不溶性微粒大小和数量显著增加,P<0.05;双室袋法配制后不增加溶液中不溶性微粒数量;注射器法配制溶液所含≥10 μm不溶性微粒数量明显多于双室袋法溶液,P<0.05。结论 双室袋法较注射器法可显著减少溶配过程中引入不溶性微粒,且不受配液环境影响,临床用药安全性更佳。
Abstract
To evaluate the clinical safety differences between 2-chamber drug delivery system method and syringe method in preparation of intravenous fluids. METHODS The light blockage method was used to record the count of insoluble particals in samples of before and after preparation through the 2-chamber drug delivery system method or syringe method. RESULTS After preparation by the syringe method, the number of insoluble particles of each particle size increased significantly, P<0.05; while the 2-chamber drug delivery system method does not increase the insoluble particle number after preparation; the solution contains significantly more ≥ 10 μm insoluble particles in the syringe method than in the 2-chamber drug delivery system method, P <0.05.CONCLUSION 2-Chamber drug delivery system method can significantly reduce the introduction of insoluble particles in the process of intravenous infusion preparation comparing with the syringe method, and despite of what the environment is, has a better clinical safety.
关键词
双室袋 /
不溶性微粒 /
光阻法 /
静脉输液
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Key words
2-chamber drug delivery system /
insoluble particle /
light blockage method /
intravenous infusion
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中图分类号：
R95
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参考文献
Ch.P(2010)VolⅡ《中国药典》2010年版.二部)[S].2010:appendix 71. TANG S F. Study for the source, harmfulness and preventive measures of particulate matter in intravenous injection .Tianjin Pharm(天津药学),2008,20(5):65. LI W S. Liquid Therapy(液体治疗学) .Beijing:China Medical Science and Technology Press,1999:63. SONG J,TANG L. The influence of dispensing environment in insoluble particles of clinical infusion .Sichuan Med J(四川药学),2007,28(1):113. JI L W,HU X,ZUO M X,et al. Studies on particulate matter of injection with butyl rubber stopper by the light blockage method . Chin Pharm J(中国药学杂志),2006,41(11):872. ZHAO L X,FENG L,YAN Y Q. Inspection and analysis of the influence of cleanliness level with insoluble particles in intravenous infusion.Gansu Med J(甘肃医药),2010,29(6):682. SHEN W J,HOU J H. The sources and prevention measures of insoluble particles in intravenous infusion . Guide of China Med(中国医药指南),2010,8(8):153. HUANG X. Effect of insoluble particle factor on the quality of infusion solution .Anqing Med J (安庆医学杂志),2002,23(3):137. WANG H S,SONG W L. The clinical use of liquid injection filter .Chinese J Nosocomiol(中华医院感染学杂志),2000,10(5):378.
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