三种冷藏药品与输液配伍后不溶性微粒的变化

Changes of Insoluble Particles in Three Types of Refrigerated Drugs after Mixture with Infusion Solution

目的了解冷藏药品与输液配伍后溶液的稳定性和溶液中不溶性微粒的变化,指导临床及时合理地使用冷藏药品,保障患者用药安全。方法参照2010版《中国药典》附录ⅣC,选择临床常用的前列地尔注射液、法莫替丁注射液和注射用水溶性维生素,观察3种冷藏药品与5%葡萄糖注射液配伍后,分别放置在室温2、4、8℃条件下储存,并于0、0.5、2、4、8、24 h取样观察溶液的澄明度,测定其pH值和≥10、≥25μm的不溶性微粒数量。结果 3种溶液在不同冷藏条件下放置不同时间,溶液的澄明度和pH值变化不大,符合要求。不溶性微粒增加,法莫替丁注射液微粒数4 h内符合要求,前列地尔注射液和注射用水溶性维生素的微粒数超过2010版《中国药典》规定。在配制完成后4℃储存条件下,4 h内所含微粒数最少。结论建议临床使用冷藏药品输液时,在配制后4℃条件下保存,4 h内使用。

Objective To study the changes of stability and insoluble particles in refrigerated drug solutions mixed with infusion solution so as to guarantee clinical safe administration. Methods Solutions of alprostadil injection,famotidine injection,water-soluble vitamin for injection were prepared with 5% glucose injection and stored at2,4,8 ℃ and room temperature for 0,0. 5,2,4,8 and 24 h. The number of ≥10 and ≥25 μm insoluble particles,the clarity and p H in the solution were detected according to the appendix IVC of Chinese Pharmacopeia（ Edition2010）. Results Three kinds of solutions were placed under different cold storage conditions for different lengths of time,resulting in little change in clarity and p H. However,the number of insoluble particles increased. The number of insoluble particles of famotidine injection met the requirement within 4 h,but alprostadil injection and water-soluble vitamin for injection exceeded the required value. Conclusion According to this study,refrigerated drug infusion should be stored under 4 ℃ and used as soon as possible within 4 h.