静脉输液配制后的微粒数变化及其影响因素探讨

目的：研究静脉输液中添加药物后其不溶性微粒数量的变化情况及其影响因素，为临床合理配制输液提供依据。方法：将添加药物按不同方式组合，加至输液中，按《中华人民共和国药典2010版》中不溶性微粒检查法进行测定。结果：在直立式聚丙烯输液袋中添加4种水针剂进行混合配制后测得的粒径大于或等于10斗m的微粒数平均值超过25个；在聚氯乙烯输液袋和直立式聚丙烯输液袋中添加5种水针剂进行混合配制后测得的粒径大于或等于10μm的微粒数平均值均超过25个，且在直立式聚丙烯输液袋测得的粒径大于或等于25μm的微粒数平均值超过3个；3种粉针剂中，注射用青霉素钠和注射用氨苄西林钠在上述2种输液袋中进行混合配制后测得的粒径大于或等于10μm的微粒数平均值均超过25个，其中注射用青霉素钠在直立式聚丙烯输液袋中所测得的粒径大于或等于25μm微粒数平均值超过3个。结论：输液中添加的药品种类越多，微粒污染越严重；直立式聚丙烯输液袋比聚氯乙烯输液袋更易产生微粒。

Change in Number of Particles in Transfusions after Adding Different Drugs and Discussion of Its Influence Factors

Objective:By studying the change in number of insoluble particles in intravenous infusions after adding different drugs and the related influence factors,to provide the basis for clinical rational intravenous infusion preparation.Methods:According to the test method for insoluble particles in Chinese Pharmacopoeia 2010 Edition,the insoluble particles in intravenous infusions after adding different drugs were measured.Results:The mean value of particles(particle size ≥ 10 μm) number was more than 25 in the vertical polypropylene(PP) infusion bag after adding four kinds of water injections.The mean value of particles(particle size ≥ 10 μm) number was more than 25 in both of the polyvinyl chloride(PVC) infusion bag and vertical PP infusion bags after adding five kinds of water injections,and more than 3 for the particles,the size of which was not less than 25 μm,in vertical PP infusion bag.The mean value of particles(particle size ≥10 μm) number was more than 25 in both of the above infusion bags,after adding benzylpenicillin sodium or ampicillin sodium injection.For the benzylpenicillin sodium,the mean value of particles(particle size ≥ 25 μm) number was more than 3 in vertical PP infusion bag.Conclusion: The more the types of drugs which were added into the infusion,the more serious was the pollution.Compared with PVC material infusion bags,it′s easier for PP bag to generate insoluble particles.