中国药物警戒 ›› 2016, Vol. 13 ›› Issue (8): 496-499.

• 安全性评价与合理用药 • 上一篇    下一篇

棓丙酯注射液与不同输液配伍的稳定性研究

张敬一, 刘阳, 刘美彤, 高声传*   

  1. 沈阳军区总医院药剂科,辽宁 沈阳 110016
  • 收稿日期:2016-09-14 修回日期:2016-09-14 出版日期:2016-08-20 发布日期:2016-09-14
  • 通讯作者: 高声传,男,硕士,主任药师,临床药学。E–mail:gao_sc2009@163.com

Study on Stability of Propylgallate Injection Combined with Different Transfusions

ZHANG Jing-yi, LIU Yang, LIU Mei-tong, GAO Sheng-chuan*   

  1. Department of Pharmaceutics, General Hospital of Shenyang Military Region, Liaoning Shenyang 110016, China
  • Received:2016-09-14 Revised:2016-09-14 Online:2016-08-20 Published:2016-09-14

摘要: 目的 考察棓丙酯注射液与不同输液配伍后的稳定性,探讨棓丙酯注射液最适配伍溶媒,为临床安全应用提供依据。方法 实验分为对照组与实验组,按照临床常用剂量与不同的输液配伍,分别在0、0.5、1、2、4、8 h时间点观察溶液的澄明度、测定溶液的pH值,按照《中国药典》2015版四部不溶性微粒检查法中光阻法测定不溶性微粒。结果 棓丙酯注射液与不同的输液配伍后,在不同时间点溶液均为透明液体,无显著性差异,澄明度符合规定,pH值的变化符合要求。不溶性微粒数随时间增加微粒数量上下浮动,与5%和10%葡萄糖注射液配伍时≥10 µm和≥25 µm的微粒数最少,符合2015版《中国药典》规定。与0.9%氯化钠注射液配伍时≥10 µm微粒数不符合规定。与葡萄糖氯化钠注射液配伍时≥10 µm的微粒在0 h时不符合规定,其他时间点符合规定。结论 棓丙酯注射液最适配伍溶媒为5%和10%葡萄糖注射液。

关键词: 棓丙酯注射液, 输液, 配伍, 稳定性

Abstract: Objective To study the stability of the solution after compatibility of the propylgallate injection with different transfusions, so as to provide favorable experimental basis for the clinical application of the propylgallate injection. Methods According to the requirements for simulation of clinical medicine, the transfusions were divided into experimental group and control group, and the changes of color, pH values, and particle numbers of compatible solutions at 0, 0.5, 1, 2, 4 h and 8 h were investigated. The numbers of particles were detected by light blockage method specified in Chinese Pharmacopeia (2015 edition, No 4). Results The compatible solutions of propylgallate injection at different time were transparent liquid, no obvious change, and there were no differences between the groups. The pH value remained stable. The numbers of particles increaseed or decreaseed with time, which reached the minimum floating when propylgallate injection combined with 5% and 10% glucose injection, conformed to the 2015 edition of Chinese Pharmacopoeia standards. The numbers of≥10 µm particles quickly increased and exceeded the limitation of the Chinese Pharmacopoeia after combined with 0.9% sodium chloride injection. The numbers of≥10 µm particles reached the maximum floating at 0 hour when propylgallate injection combined with glucose-sodium chloride injection. At other times, the numbers of insoluble particles were qualified. Conclusion The most compatible suitable solvents for propylgallate injection were 5% glucose injection and 10% glucose injection.

Key words: propylgallate injection, transfusion, combination, stability

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