摘要
目的了解儿童常用药与不同基础输液配伍后不溶性微粒的差别,为临床输液产品的遴选提供依据。方法选取4种儿科临床常用的注射药品,以及北京地区市面上销售份额排名靠前的4家输液产品(内封式聚丙烯输液袋BFS,双层无菌软袋,单管软袋,双阀软袋,编号为输液A、B、C、D),分别测定空白输液及与4种药品(注射用阿奇霉素、注射用磷酸肌酸钠、复方甘草酸单铵S注射液、盐酸氨溴索注射液)分别配伍后的输液中,2μm以上全粒径范围的不溶性微粒数量,并进行组间比较。结果空白输液组间比较,输液A所含不溶性微粒数量最少,输液D所含不溶性微粒数量显著高于其他3种。相同药品与不同基础输液复配后比较,输液D显著高于其他3种输液;相同输液与不同药品复配后比较,药品1复配溶液所含不溶性微粒明显高于其他3种药品(P <0. 01)。计算复配后2~10μm不溶性微粒占比显示,小粒径微粒均占总体微粒数90%以上。结论不同输液产品与儿科常用药品复配后溶液中不溶性微粒数量具有显著差异,提示儿科临床需重视输液产品的遴选。
Objective Foundation of select the pediatric drugs is provided by investigate the insoluble particles in different basic infusion.Methods Four kind of pediatric drugs( azithromycin for injection,sodium phosphocreatine for injection,compound ammonium glycyrrhetate S injection andambroxol hydrochloride injection) and four kinds of sodium chloride injection( BFS,double aseptic soft bag,single tube soft bag and double soft bag,numbered as infusion A,B,C,D),the sales volume of which were top 4 in Beijing were selected,and test the content of ≥2μm insoluble particles which per and post the different sodium chloride injection compatible with pediatric drugs. The content between different groups were compared. Results The content of insoluble particles in infusion A was the lowest in four kind of infusions,the number of infusion D was much higher than others before compatible with pediatric drugs.The content of insoluble particle in infusion which was matched with drug 1 was much higher than other groups( P < 0. 01). The content of 2-10μm insoluble particle was over 90% than total. Conclusion In this study,the outstanding difference was found that the content of insoluble particles in the different sodium chloride injection which was matched with pediatric drugs. It shows that it's necessary to pay attention to the selection of infusion in pediatrics.
引文
[1]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2017年)[J].中国药物评价,2018,35(2):154-160.
[2]赵广娟.临床输液反应288例分析及对策[J].中国实用医药,2008,3(12):61-62.
[3]彭姝,张军,李慧芬,等.输液中不溶性微粒的危害综述[J].中国药事,2018,32(8):1058-1063.
[4]罗宇,张晓霞,封卫毅,等.静脉药物配置方法对产生微粒数量的影响[J].护理管理杂志,2016,16(9):649-651.
[5]李英,王宇航,赵立波,等.双室袋法与注射器法配制静脉输液的不溶性微粒比较[J].中国药学杂志,2013,48(22):1969-1971.
[6]石崇爱,陈凤莲,詹月敏,等.药物配置过程中不溶性微粒的来源分析及控制措施[J].海峡药学,2016,28(10):224-225.
[7]梅丹,李大魁,张继春,等.静脉滴注用抗生素粉针剂中不溶性微粒考察[J].中国药学杂志,1999,34(10):24-26.
[8]朱斌,赵志刚.守护针尖上的安全——中国输液安全与防护专家共识[J].药品评价,2016,13(10):8-17.